Trial Outcomes & Findings for A Multicenter, Open-Label, Non-Comparative Study of the Safety and Contraceptive Efficacy of the Woman's Condom (NCT NCT01223313)
NCT ID: NCT01223313
Last Updated: 2026-02-09
Results Overview
Pearl rate will be calculated based on the number of woman-months that the subject was at risk for pregnancy. Woman-months of pregnancy risk is defined as the (last date study product considered primary means of contraception - date of enrollment + 1) / 30.4 for women who are not pregnant and as (date of conception - date of enrollment + 1) / 30.4 for women who became pregnant during the study.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
511 participants
Primary outcome timeframe
6 Months
Results posted on
2026-02-09
Participant Flow
The study was designed to enroll 500 participants. However, the study enrolled 511 participants.
Participant milestones
| Measure |
Woman's Condom
The Woman's Condom (WC) is an investigational device manufactured by Shanghai Dahua Medical Apparatus Corp., Ltd (Dahua). The WC consists of a 0.03-mm-thick pliable plastic pouch that easily conforms to the shape of the vagina. It is 22.9 cm (± 0.3 cm)(9 inches ± 0.1 inch) long and has a flexible soft outer ring that is designed to hug the external genitalia. The insertion capsule is made from dissolvable polyvinyl alcohol (PVA) and is similar to the PVA used in C-Film (Apothecus Pharmaceutical Corporation, New York, NY). The WC is a non-lubricated device. It is supplied with water-soluble lubricant with a chemical composition similar to a commercially available lubricant used in previous studies of the WC.
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Overall Study
STARTED
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511
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Overall Study
COMPLETED
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278
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Overall Study
NOT COMPLETED
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233
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Multicenter, Open-Label, Non-Comparative Study of the Safety and Contraceptive Efficacy of the Woman's Condom
Baseline characteristics by cohort
| Measure |
Woman's Condom
n=511 Participants
The Woman's Condom (WC) is an investigational device manufactured by Shanghai Dahua Medical Apparatus Corp., Ltd (Dahua). The WC consists of a 0.03-mm-thick pliable plastic pouch that easily conforms to the shape of the vagina. It is 22.9 cm (± 0.3 cm)(9 inches ± 0.1 inch) long and has a flexible soft outer ring that is designed to hug the external genitalia. The insertion capsule is made from dissolvable polyvinyl alcohol (PVA) and is similar to the PVA used in C-Film (Apothecus Pharmaceutical Corporation, New York, NY). The WC is a non-lubricated device. It is supplied with water-soluble lubricant with a chemical composition similar to a commercially available lubricant used in previous studies of the WC.
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Age, Categorical
<=18 years
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0 Participants
n=41 Participants
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Age, Categorical
Between 18 and 65 years
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511 Participants
n=41 Participants
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Age, Categorical
>=65 years
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0 Participants
n=41 Participants
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Age, Continuous
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28.4 years
STANDARD_DEVIATION 6.13 • n=41 Participants
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Sex: Female, Male
Female
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511 Participants
n=41 Participants
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Sex: Female, Male
Male
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0 Participants
n=41 Participants
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Region of Enrollment
United States
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511 participants
n=41 Participants
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PRIMARY outcome
Timeframe: Assessed at 1 Month, 3 Months, and 6 Months, up to 6 MonthsPopulation: enrolled subjects whose diaries indicated they had at least one episode of coitus while using the assigned study product and for whom there is at least one report of pregnancy status.
Kaplan-Meier methods will be used to estimate the six-month cumulative pregnancy probability of women in the MITT population. Pregnancies are not included if they are found to have occurred before a subject was enrolled or after she has discontinued using the study product as her primary method of contraception. The pregnancy probability is reported as a percentage.
Outcome measures
| Measure |
Woman's Condom
n=401 Participants
The Woman's Condom (WC) is an investigational device manufactured by Shanghai Dahua Medical Apparatus Corp., Ltd (Dahua). Dahua's quality management system complies with ISO9001:2000, ISO13485:2003, MDD93/42/EEC. The WC consists of a 0.03-mm-thick pliable plastic pouch that easily conforms to the shape of the vagina. It is 22.9 cm (± 0.3 cm)(9 inches ± 0.1 inch) long and has a flexible soft outer ring that is designed to hug the external genitalia. The foam shapes on the outside of the pouch cling lightly to vaginal walls, ensuring stability of the device. The insertion capsule is made from dissolvable polyvinyl alcohol (PVA) and is similar to the PVA used in C-Film (Apothecus Pharmaceutical Corporation, New York, NY). The WC is a non-lubricated device. It is supplied with water-soluble lubricant with a chemical composition similar to a commercially available lubricant used in previous studies of the WC.
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6 Month Pregnancy Probabilities With Typical Use
1 Month Pregnancy Probability
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0.5 percentage of probability
Interval 0.0 to 1.2
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6 Month Pregnancy Probabilities With Typical Use
3 Month Pregnancy Probability
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1.4 percentage of probability
Interval 0.1 to 2.6
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6 Month Pregnancy Probabilities With Typical Use
6 Month Pregnancy Probability
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4.0 percentage of probability
Interval 1.6 to 6.3
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PRIMARY outcome
Timeframe: 6 MonthsPopulation: enrolled subjects whose diaries indicated they had at least one episode of coitus while using the assigned study product and for whom there is at least one report of pregnancy status.
Pearl rate will be calculated based on the number of woman-months that the subject was at risk for pregnancy. Woman-months of pregnancy risk is defined as the (last date study product considered primary means of contraception - date of enrollment + 1) / 30.4 for women who are not pregnant and as (date of conception - date of enrollment + 1) / 30.4 for women who became pregnant during the study.
Outcome measures
| Measure |
Woman's Condom
n=2241 Months
The Woman's Condom (WC) is an investigational device manufactured by Shanghai Dahua Medical Apparatus Corp., Ltd (Dahua). Dahua's quality management system complies with ISO9001:2000, ISO13485:2003, MDD93/42/EEC. The WC consists of a 0.03-mm-thick pliable plastic pouch that easily conforms to the shape of the vagina. It is 22.9 cm (± 0.3 cm)(9 inches ± 0.1 inch) long and has a flexible soft outer ring that is designed to hug the external genitalia. The foam shapes on the outside of the pouch cling lightly to vaginal walls, ensuring stability of the device. The insertion capsule is made from dissolvable polyvinyl alcohol (PVA) and is similar to the PVA used in C-Film (Apothecus Pharmaceutical Corporation, New York, NY). The WC is a non-lubricated device. It is supplied with water-soluble lubricant with a chemical composition similar to a commercially available lubricant used in previous studies of the WC.
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6 Month Pearl Rate With Typical Use
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8.03 Pregnancies per 100 women-years
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SECONDARY outcome
Timeframe: Assessed at 1 Month, 3 Months, and 6 Months, up to 6 MonthsPopulation: enrolled subjects whose diaries indicated they had used the assigned study product correctly for every coital act for at least one menstrual cycle and for whom there is at least one report of pregnancy status.
Kaplan-Meier methods will be used to estimate the six-month cumulative pregnancy probability of women in the Efficacy Evaluable population. Each woman in the Efficacy Evaluable population contributes efficacy for menstrual cycles where she has used the assigned product consistently and correctly as reflected in her diary recordings. Pregnancies that are found to have occurred before a subject was enrolled or after she has discontinued using the study product as her primary method of contraception are not included. The pregnancy probability is reported as a percentage.
Outcome measures
| Measure |
Woman's Condom
n=277 Participants
The Woman's Condom (WC) is an investigational device manufactured by Shanghai Dahua Medical Apparatus Corp., Ltd (Dahua). Dahua's quality management system complies with ISO9001:2000, ISO13485:2003, MDD93/42/EEC. The WC consists of a 0.03-mm-thick pliable plastic pouch that easily conforms to the shape of the vagina. It is 22.9 cm (± 0.3 cm)(9 inches ± 0.1 inch) long and has a flexible soft outer ring that is designed to hug the external genitalia. The foam shapes on the outside of the pouch cling lightly to vaginal walls, ensuring stability of the device. The insertion capsule is made from dissolvable polyvinyl alcohol (PVA) and is similar to the PVA used in C-Film (Apothecus Pharmaceutical Corporation, New York, NY). The WC is a non-lubricated device. It is supplied with water-soluble lubricant with a chemical composition similar to a commercially available lubricant used in previous studies of the WC.
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6 Month Pregnancy Probabilities With Perfect Use
1 Month Pregnancy Probability
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0.0 percentage of probability
Interval 0.0 to 0.0
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6 Month Pregnancy Probabilities With Perfect Use
3 Month Pregnancy Probability
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0.4 percentage of probability
Interval 0.0 to 1.1
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6 Month Pregnancy Probabilities With Perfect Use
6 Month Pregnancy Probability
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2.6 percentage of probability
Interval 0.4 to 4.7
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SECONDARY outcome
Timeframe: Visit 1 (Screening) and Visit 3 (Exit), up to 6 monthsPopulation: Subjects that used at least one Woman's Condom and had chlamydia test performed at the respective visits
Incidence of acquisition of Chlamydia evaluated at screening and end of the study.
Outcome measures
| Measure |
Woman's Condom
n=405 Participants
The Woman's Condom (WC) is an investigational device manufactured by Shanghai Dahua Medical Apparatus Corp., Ltd (Dahua). Dahua's quality management system complies with ISO9001:2000, ISO13485:2003, MDD93/42/EEC. The WC consists of a 0.03-mm-thick pliable plastic pouch that easily conforms to the shape of the vagina. It is 22.9 cm (± 0.3 cm)(9 inches ± 0.1 inch) long and has a flexible soft outer ring that is designed to hug the external genitalia. The foam shapes on the outside of the pouch cling lightly to vaginal walls, ensuring stability of the device. The insertion capsule is made from dissolvable polyvinyl alcohol (PVA) and is similar to the PVA used in C-Film (Apothecus Pharmaceutical Corporation, New York, NY). The WC is a non-lubricated device. It is supplied with water-soluble lubricant with a chemical composition similar to a commercially available lubricant used in previous studies of the WC.
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Incidence of Chlamydia During the Study
Positive Chlamydia at Visit 1/Screening
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7 Participants
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Incidence of Chlamydia During the Study
Positive Chlamydia at Visit 3/Exit
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4 Participants
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SECONDARY outcome
Timeframe: Visit 1 (Screening) and Visit 3 (Exit), up to 6 monthsPopulation: Subjects that used at least one Woman's Condom and had gonorrhea test performed at the respective visits
Incidence of acquisition of Gonorrhea evaluated at screening and end of the study.
Outcome measures
| Measure |
Woman's Condom
n=405 Participants
The Woman's Condom (WC) is an investigational device manufactured by Shanghai Dahua Medical Apparatus Corp., Ltd (Dahua). Dahua's quality management system complies with ISO9001:2000, ISO13485:2003, MDD93/42/EEC. The WC consists of a 0.03-mm-thick pliable plastic pouch that easily conforms to the shape of the vagina. It is 22.9 cm (± 0.3 cm)(9 inches ± 0.1 inch) long and has a flexible soft outer ring that is designed to hug the external genitalia. The foam shapes on the outside of the pouch cling lightly to vaginal walls, ensuring stability of the device. The insertion capsule is made from dissolvable polyvinyl alcohol (PVA) and is similar to the PVA used in C-Film (Apothecus Pharmaceutical Corporation, New York, NY). The WC is a non-lubricated device. It is supplied with water-soluble lubricant with a chemical composition similar to a commercially available lubricant used in previous studies of the WC.
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Incidence of Gonorrhea During the Study
Positive Gonorrhea at Visit 1/Screening
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4 Participants
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Incidence of Gonorrhea During the Study
Positive Gonorrhea at Visit 3/Exit
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6 Participants
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SECONDARY outcome
Timeframe: Visit 1/Screening and Visit 3/Exit, up to 6 monthsPopulation: only subjects that had both a baseline and exit visit UTI screening were included in the analysis
Change from Baseline of urinary tract infections (UTIs)
Outcome measures
| Measure |
Woman's Condom
n=378 Participants
The Woman's Condom (WC) is an investigational device manufactured by Shanghai Dahua Medical Apparatus Corp., Ltd (Dahua). Dahua's quality management system complies with ISO9001:2000, ISO13485:2003, MDD93/42/EEC. The WC consists of a 0.03-mm-thick pliable plastic pouch that easily conforms to the shape of the vagina. It is 22.9 cm (± 0.3 cm)(9 inches ± 0.1 inch) long and has a flexible soft outer ring that is designed to hug the external genitalia. The foam shapes on the outside of the pouch cling lightly to vaginal walls, ensuring stability of the device. The insertion capsule is made from dissolvable polyvinyl alcohol (PVA) and is similar to the PVA used in C-Film (Apothecus Pharmaceutical Corporation, New York, NY). The WC is a non-lubricated device. It is supplied with water-soluble lubricant with a chemical composition similar to a commercially available lubricant used in previous studies of the WC.
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Change From Baseline in Urinary Tract Infections (UTIs)
Subjects with No Change from Baseline
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373 Participants
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Change From Baseline in Urinary Tract Infections (UTIs)
Subjects Improved from Baseline
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2 Participants
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Change From Baseline in Urinary Tract Infections (UTIs)
Subjects Worsened from Baseline
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3 Participants
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SECONDARY outcome
Timeframe: Visit 1/Screening and Visit 3/Exit, up to 6 monthsPopulation: only subjects that had both a baseline and exit visit BV screening were included in the analysis
Change from Baseline of bacterial vaginosis (BV)
Outcome measures
| Measure |
Woman's Condom
n=234 Participants
The Woman's Condom (WC) is an investigational device manufactured by Shanghai Dahua Medical Apparatus Corp., Ltd (Dahua). Dahua's quality management system complies with ISO9001:2000, ISO13485:2003, MDD93/42/EEC. The WC consists of a 0.03-mm-thick pliable plastic pouch that easily conforms to the shape of the vagina. It is 22.9 cm (± 0.3 cm)(9 inches ± 0.1 inch) long and has a flexible soft outer ring that is designed to hug the external genitalia. The foam shapes on the outside of the pouch cling lightly to vaginal walls, ensuring stability of the device. The insertion capsule is made from dissolvable polyvinyl alcohol (PVA) and is similar to the PVA used in C-Film (Apothecus Pharmaceutical Corporation, New York, NY). The WC is a non-lubricated device. It is supplied with water-soluble lubricant with a chemical composition similar to a commercially available lubricant used in previous studies of the WC.
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Change From Baseline in Bacterial Vaginosis (BV)
Subjects with No Change from Baseline
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222 Participants
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Change From Baseline in Bacterial Vaginosis (BV)
Subjects Improved from Baseline
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3 Participants
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Change From Baseline in Bacterial Vaginosis (BV)
Subjects Worsened from Baseline
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9 Participants
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SECONDARY outcome
Timeframe: Visit 1/Screening and Visit 3/Exit, up to 6 monthsPopulation: only subjects that had both a baseline and exit visit monilia screening were included in the analysis
Change from Baseline of Monilia
Outcome measures
| Measure |
Woman's Condom
n=10 Participants
The Woman's Condom (WC) is an investigational device manufactured by Shanghai Dahua Medical Apparatus Corp., Ltd (Dahua). Dahua's quality management system complies with ISO9001:2000, ISO13485:2003, MDD93/42/EEC. The WC consists of a 0.03-mm-thick pliable plastic pouch that easily conforms to the shape of the vagina. It is 22.9 cm (± 0.3 cm)(9 inches ± 0.1 inch) long and has a flexible soft outer ring that is designed to hug the external genitalia. The foam shapes on the outside of the pouch cling lightly to vaginal walls, ensuring stability of the device. The insertion capsule is made from dissolvable polyvinyl alcohol (PVA) and is similar to the PVA used in C-Film (Apothecus Pharmaceutical Corporation, New York, NY). The WC is a non-lubricated device. It is supplied with water-soluble lubricant with a chemical composition similar to a commercially available lubricant used in previous studies of the WC.
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Change From Baseline in Monilia
Subjects with No Change from Baseline
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10 Participants
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Change From Baseline in Monilia
Subjects Improved from Baseline
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0 Participants
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Change From Baseline in Monilia
Subjects Worsened from Baseline
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0 Participants
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SECONDARY outcome
Timeframe: Visit 1 (Screening) and Visit 3 (Exit), up to 6 monthsPopulation: Subjects that used at least one Woman's Condom and had trichomoniasis test performed at the respective visits. Subjects were only tested for trichomoniasis if clinically indicated. Therefore, not all subjects were tested. Only 12 subjects were tested for trichomoniasis based on clinical indication for testing.
Incidence of acquisition of Trichomoniasis evaluated at screening and end of the study.
Outcome measures
| Measure |
Woman's Condom
n=12 Participants
The Woman's Condom (WC) is an investigational device manufactured by Shanghai Dahua Medical Apparatus Corp., Ltd (Dahua). Dahua's quality management system complies with ISO9001:2000, ISO13485:2003, MDD93/42/EEC. The WC consists of a 0.03-mm-thick pliable plastic pouch that easily conforms to the shape of the vagina. It is 22.9 cm (± 0.3 cm)(9 inches ± 0.1 inch) long and has a flexible soft outer ring that is designed to hug the external genitalia. The foam shapes on the outside of the pouch cling lightly to vaginal walls, ensuring stability of the device. The insertion capsule is made from dissolvable polyvinyl alcohol (PVA) and is similar to the PVA used in C-Film (Apothecus Pharmaceutical Corporation, New York, NY). The WC is a non-lubricated device. It is supplied with water-soluble lubricant with a chemical composition similar to a commercially available lubricant used in previous studies of the WC.
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Incidence of Trichomoniasis During the Study
Positive Gonorrhea at Visit 1/Screening
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3 Participants
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Incidence of Trichomoniasis During the Study
Positive Gonorrhea at Visit 3/Exit
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0 Participants
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SECONDARY outcome
Timeframe: Visit 3 (Cycle 6), up to 6 monthsPopulation: Subjects that completed the questionnaire at exit visit were analyzed
Acceptability of the Woman's Condom as measured by an acceptability questionnaire administered at study exit (visit 3, after menstrual cycle 6 or early discontinuation).
Outcome measures
| Measure |
Woman's Condom
n=337 Participants
The Woman's Condom (WC) is an investigational device manufactured by Shanghai Dahua Medical Apparatus Corp., Ltd (Dahua). Dahua's quality management system complies with ISO9001:2000, ISO13485:2003, MDD93/42/EEC. The WC consists of a 0.03-mm-thick pliable plastic pouch that easily conforms to the shape of the vagina. It is 22.9 cm (± 0.3 cm)(9 inches ± 0.1 inch) long and has a flexible soft outer ring that is designed to hug the external genitalia. The foam shapes on the outside of the pouch cling lightly to vaginal walls, ensuring stability of the device. The insertion capsule is made from dissolvable polyvinyl alcohol (PVA) and is similar to the PVA used in C-Film (Apothecus Pharmaceutical Corporation, New York, NY). The WC is a non-lubricated device. It is supplied with water-soluble lubricant with a chemical composition similar to a commercially available lubricant used in previous studies of the WC.
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Number of Women That Preferred Female Condom Over Male Condom After Cycle 6
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81 Participants
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SECONDARY outcome
Timeframe: Up to 6 months of usePopulation: Subjects that used the Woman's Condom were analyzed
Performance of the Woman's Condom as assessed by self-reported clinical breakage based on percent of uses. Breakage of the female condom during intercourse or during withdrawal of the condom from the vagina. Clinical breakage is breakage with potential adverse health consequences and includes events in which the outer frame or ring breaks. It is calculated by dividing the number of female condoms reported to have broken during intercourse or withdrawal by the number of female condoms used during intercourse.
Outcome measures
| Measure |
Woman's Condom
n=405 Participants
The Woman's Condom (WC) is an investigational device manufactured by Shanghai Dahua Medical Apparatus Corp., Ltd (Dahua). Dahua's quality management system complies with ISO9001:2000, ISO13485:2003, MDD93/42/EEC. The WC consists of a 0.03-mm-thick pliable plastic pouch that easily conforms to the shape of the vagina. It is 22.9 cm (± 0.3 cm)(9 inches ± 0.1 inch) long and has a flexible soft outer ring that is designed to hug the external genitalia. The foam shapes on the outside of the pouch cling lightly to vaginal walls, ensuring stability of the device. The insertion capsule is made from dissolvable polyvinyl alcohol (PVA) and is similar to the PVA used in C-Film (Apothecus Pharmaceutical Corporation, New York, NY). The WC is a non-lubricated device. It is supplied with water-soluble lubricant with a chemical composition similar to a commercially available lubricant used in previous studies of the WC.
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Percentage of Uses With Clinical Breakage With the Woman's Condom
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1.2 percentage
Standard Deviation 6.44
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SECONDARY outcome
Timeframe: Up to 6 months of usePopulation: Subjects that used the Woman's Condom were analyzed
Performance of the Woman's Condom as assessed by self-reported misdirection based on percent of uses. Vaginal penetration whereby the penis is inserted between the female condom and the vaginal wall and is calculated by dividing the number of reported incidences of misdirection by the number of female condoms used during intercourse.
Outcome measures
| Measure |
Woman's Condom
n=405 Participants
The Woman's Condom (WC) is an investigational device manufactured by Shanghai Dahua Medical Apparatus Corp., Ltd (Dahua). Dahua's quality management system complies with ISO9001:2000, ISO13485:2003, MDD93/42/EEC. The WC consists of a 0.03-mm-thick pliable plastic pouch that easily conforms to the shape of the vagina. It is 22.9 cm (± 0.3 cm)(9 inches ± 0.1 inch) long and has a flexible soft outer ring that is designed to hug the external genitalia. The foam shapes on the outside of the pouch cling lightly to vaginal walls, ensuring stability of the device. The insertion capsule is made from dissolvable polyvinyl alcohol (PVA) and is similar to the PVA used in C-Film (Apothecus Pharmaceutical Corporation, New York, NY). The WC is a non-lubricated device. It is supplied with water-soluble lubricant with a chemical composition similar to a commercially available lubricant used in previous studies of the WC.
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Percentage of Uses With Misdirection With the Woman's Condom
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2.2 percentage
Standard Deviation 7.79
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SECONDARY outcome
Timeframe: Up to 6 months of usePopulation: Subjects that used the Woman's Condom were analyzed
Performance of the Woman's Condom as assessed by self-reported slippage based on percent of uses. A female condom that slips completely out of the vagina during intercourse and is calculated by dividing the number of female condoms that slipped during intercourse by the number of female condoms used during intercourse.
Outcome measures
| Measure |
Woman's Condom
n=405 Participants
The Woman's Condom (WC) is an investigational device manufactured by Shanghai Dahua Medical Apparatus Corp., Ltd (Dahua). Dahua's quality management system complies with ISO9001:2000, ISO13485:2003, MDD93/42/EEC. The WC consists of a 0.03-mm-thick pliable plastic pouch that easily conforms to the shape of the vagina. It is 22.9 cm (± 0.3 cm)(9 inches ± 0.1 inch) long and has a flexible soft outer ring that is designed to hug the external genitalia. The foam shapes on the outside of the pouch cling lightly to vaginal walls, ensuring stability of the device. The insertion capsule is made from dissolvable polyvinyl alcohol (PVA) and is similar to the PVA used in C-Film (Apothecus Pharmaceutical Corporation, New York, NY). The WC is a non-lubricated device. It is supplied with water-soluble lubricant with a chemical composition similar to a commercially available lubricant used in previous studies of the WC.
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Percentage of Uses With Slippage With the Woman's Condom
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4.3 percentage
Standard Deviation 13.24
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SECONDARY outcome
Timeframe: Up to 6 months of usePopulation: Subjects that used the Woman's Condom were analyzed
Performance of the Woman's Condom as assessed by self-reported invagination based on percent of uses. As part of the entire external component of the female condom being pushed into the vagina during intercourse and is calculated by dividing the number of reported incidences of invagination during intercourse by the number of female condoms used during intercourse.
Outcome measures
| Measure |
Woman's Condom
n=405 Participants
The Woman's Condom (WC) is an investigational device manufactured by Shanghai Dahua Medical Apparatus Corp., Ltd (Dahua). Dahua's quality management system complies with ISO9001:2000, ISO13485:2003, MDD93/42/EEC. The WC consists of a 0.03-mm-thick pliable plastic pouch that easily conforms to the shape of the vagina. It is 22.9 cm (± 0.3 cm)(9 inches ± 0.1 inch) long and has a flexible soft outer ring that is designed to hug the external genitalia. The foam shapes on the outside of the pouch cling lightly to vaginal walls, ensuring stability of the device. The insertion capsule is made from dissolvable polyvinyl alcohol (PVA) and is similar to the PVA used in C-Film (Apothecus Pharmaceutical Corporation, New York, NY). The WC is a non-lubricated device. It is supplied with water-soluble lubricant with a chemical composition similar to a commercially available lubricant used in previous studies of the WC.
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Percentage of Uses With Invagination With the Woman's Condom
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1.9 percentage
Standard Deviation 7.48
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SECONDARY outcome
Timeframe: Up to 6 months of usePopulation: Subjects that used the Woman's Condom were analyzed
Performance of the Woman's Condom as assessed by total clinical failure based on percent of uses. Total Clinical Failure is defined as the number of female condoms that clinically break, slip, or are associated with reported incidences of misdirection or invagination during intercourse (i.e., any event that might lead to semen spillage) and is calculated by dividing the sum of these events by the number of female condoms used during intercourse.
Outcome measures
| Measure |
Woman's Condom
n=405 Participants
The Woman's Condom (WC) is an investigational device manufactured by Shanghai Dahua Medical Apparatus Corp., Ltd (Dahua). Dahua's quality management system complies with ISO9001:2000, ISO13485:2003, MDD93/42/EEC. The WC consists of a 0.03-mm-thick pliable plastic pouch that easily conforms to the shape of the vagina. It is 22.9 cm (± 0.3 cm)(9 inches ± 0.1 inch) long and has a flexible soft outer ring that is designed to hug the external genitalia. The foam shapes on the outside of the pouch cling lightly to vaginal walls, ensuring stability of the device. The insertion capsule is made from dissolvable polyvinyl alcohol (PVA) and is similar to the PVA used in C-Film (Apothecus Pharmaceutical Corporation, New York, NY). The WC is a non-lubricated device. It is supplied with water-soluble lubricant with a chemical composition similar to a commercially available lubricant used in previous studies of the WC.
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Percentage of Uses With Total Clinical Failure With the Woman's Condom
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8.0 percentage
Standard Deviation 16.31
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Adverse Events
Woman's Condom
Serious events: 1 serious events
Other events: 102 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Woman's Condom
n=405 participants at risk
The Woman's Condom (WC) is an investigational device manufactured by Shanghai Dahua Medical Apparatus Corp., Ltd (Dahua). Dahua's quality management system complies with ISO9001:2000, ISO13485:2003, MDD93/42/EEC. The WC consists of a 0.03-mm-thick pliable plastic pouch that easily conforms to the shape of the vagina. It is 22.9 cm (± 0.3 cm)(9 inches ± 0.1 inch) long and has a flexible soft outer ring that is designed to hug the external genitalia. The foam shapes on the outside of the pouch cling lightly to vaginal walls, ensuring stability of the device. The insertion capsule is made from dissolvable polyvinyl alcohol (PVA) and is similar to the PVA used in C-Film (Apothecus Pharmaceutical Corporation, New York, NY). The WC is a non-lubricated device. It is supplied with water-soluble lubricant with a chemical composition similar to a commercially available lubricant used in previous studies of the WC.
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|---|---|
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Nervous system disorders
Convulsion
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0.25%
1/405 • Number of events 1 • 6 months, immediately after informed consent has been obtained and lasts through the study Exit Visit, up to 6 months.
For this study, an Adverse Event (AE) is defined as one following: 1) any genital or urinary tract problem that lasts more than an hour, 2) any non-genital/urinary tract problem that is at least possibly related to condom use, or 3) a serious adverse event. The transient symptoms associated with the use of the study condom will not be reported as AEs. Those symptoms include irritation, itching, burning, rash, abnormal discharge (not including gel), odor, or pain or difficulty in urination.
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Other adverse events
| Measure |
Woman's Condom
n=405 participants at risk
The Woman's Condom (WC) is an investigational device manufactured by Shanghai Dahua Medical Apparatus Corp., Ltd (Dahua). Dahua's quality management system complies with ISO9001:2000, ISO13485:2003, MDD93/42/EEC. The WC consists of a 0.03-mm-thick pliable plastic pouch that easily conforms to the shape of the vagina. It is 22.9 cm (± 0.3 cm)(9 inches ± 0.1 inch) long and has a flexible soft outer ring that is designed to hug the external genitalia. The foam shapes on the outside of the pouch cling lightly to vaginal walls, ensuring stability of the device. The insertion capsule is made from dissolvable polyvinyl alcohol (PVA) and is similar to the PVA used in C-Film (Apothecus Pharmaceutical Corporation, New York, NY). The WC is a non-lubricated device. It is supplied with water-soluble lubricant with a chemical composition similar to a commercially available lubricant used in previous studies of the WC.
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Gastrointestinal disorders
Abdominal pain
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0.49%
2/405 • Number of events 2 • 6 months, immediately after informed consent has been obtained and lasts through the study Exit Visit, up to 6 months.
For this study, an Adverse Event (AE) is defined as one following: 1) any genital or urinary tract problem that lasts more than an hour, 2) any non-genital/urinary tract problem that is at least possibly related to condom use, or 3) a serious adverse event. The transient symptoms associated with the use of the study condom will not be reported as AEs. Those symptoms include irritation, itching, burning, rash, abnormal discharge (not including gel), odor, or pain or difficulty in urination.
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Gastrointestinal disorders
Abdominal pain lower
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0.25%
1/405 • Number of events 1 • 6 months, immediately after informed consent has been obtained and lasts through the study Exit Visit, up to 6 months.
For this study, an Adverse Event (AE) is defined as one following: 1) any genital or urinary tract problem that lasts more than an hour, 2) any non-genital/urinary tract problem that is at least possibly related to condom use, or 3) a serious adverse event. The transient symptoms associated with the use of the study condom will not be reported as AEs. Those symptoms include irritation, itching, burning, rash, abnormal discharge (not including gel), odor, or pain or difficulty in urination.
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Infections and infestations
Cervicitis trichomonal
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0.25%
1/405 • Number of events 1 • 6 months, immediately after informed consent has been obtained and lasts through the study Exit Visit, up to 6 months.
For this study, an Adverse Event (AE) is defined as one following: 1) any genital or urinary tract problem that lasts more than an hour, 2) any non-genital/urinary tract problem that is at least possibly related to condom use, or 3) a serious adverse event. The transient symptoms associated with the use of the study condom will not be reported as AEs. Those symptoms include irritation, itching, burning, rash, abnormal discharge (not including gel), odor, or pain or difficulty in urination.
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Infections and infestations
Chlamydial infection
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1.5%
6/405 • Number of events 6 • 6 months, immediately after informed consent has been obtained and lasts through the study Exit Visit, up to 6 months.
For this study, an Adverse Event (AE) is defined as one following: 1) any genital or urinary tract problem that lasts more than an hour, 2) any non-genital/urinary tract problem that is at least possibly related to condom use, or 3) a serious adverse event. The transient symptoms associated with the use of the study condom will not be reported as AEs. Those symptoms include irritation, itching, burning, rash, abnormal discharge (not including gel), odor, or pain or difficulty in urination.
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Infections and infestations
Fungal infection
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0.49%
2/405 • Number of events 2 • 6 months, immediately after informed consent has been obtained and lasts through the study Exit Visit, up to 6 months.
For this study, an Adverse Event (AE) is defined as one following: 1) any genital or urinary tract problem that lasts more than an hour, 2) any non-genital/urinary tract problem that is at least possibly related to condom use, or 3) a serious adverse event. The transient symptoms associated with the use of the study condom will not be reported as AEs. Those symptoms include irritation, itching, burning, rash, abnormal discharge (not including gel), odor, or pain or difficulty in urination.
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Infections and infestations
Gonorrhoea
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0.49%
2/405 • Number of events 2 • 6 months, immediately after informed consent has been obtained and lasts through the study Exit Visit, up to 6 months.
For this study, an Adverse Event (AE) is defined as one following: 1) any genital or urinary tract problem that lasts more than an hour, 2) any non-genital/urinary tract problem that is at least possibly related to condom use, or 3) a serious adverse event. The transient symptoms associated with the use of the study condom will not be reported as AEs. Those symptoms include irritation, itching, burning, rash, abnormal discharge (not including gel), odor, or pain or difficulty in urination.
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Infections and infestations
Pelvic inflammatory disease
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0.25%
1/405 • Number of events 1 • 6 months, immediately after informed consent has been obtained and lasts through the study Exit Visit, up to 6 months.
For this study, an Adverse Event (AE) is defined as one following: 1) any genital or urinary tract problem that lasts more than an hour, 2) any non-genital/urinary tract problem that is at least possibly related to condom use, or 3) a serious adverse event. The transient symptoms associated with the use of the study condom will not be reported as AEs. Those symptoms include irritation, itching, burning, rash, abnormal discharge (not including gel), odor, or pain or difficulty in urination.
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Infections and infestations
Urinary tract infection
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4.2%
17/405 • Number of events 17 • 6 months, immediately after informed consent has been obtained and lasts through the study Exit Visit, up to 6 months.
For this study, an Adverse Event (AE) is defined as one following: 1) any genital or urinary tract problem that lasts more than an hour, 2) any non-genital/urinary tract problem that is at least possibly related to condom use, or 3) a serious adverse event. The transient symptoms associated with the use of the study condom will not be reported as AEs. Those symptoms include irritation, itching, burning, rash, abnormal discharge (not including gel), odor, or pain or difficulty in urination.
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Infections and infestations
Vaginitis bacterial
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4.7%
19/405 • Number of events 19 • 6 months, immediately after informed consent has been obtained and lasts through the study Exit Visit, up to 6 months.
For this study, an Adverse Event (AE) is defined as one following: 1) any genital or urinary tract problem that lasts more than an hour, 2) any non-genital/urinary tract problem that is at least possibly related to condom use, or 3) a serious adverse event. The transient symptoms associated with the use of the study condom will not be reported as AEs. Those symptoms include irritation, itching, burning, rash, abnormal discharge (not including gel), odor, or pain or difficulty in urination.
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Infections and infestations
Vulvovaginal candidiasis
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0.49%
2/405 • Number of events 2 • 6 months, immediately after informed consent has been obtained and lasts through the study Exit Visit, up to 6 months.
For this study, an Adverse Event (AE) is defined as one following: 1) any genital or urinary tract problem that lasts more than an hour, 2) any non-genital/urinary tract problem that is at least possibly related to condom use, or 3) a serious adverse event. The transient symptoms associated with the use of the study condom will not be reported as AEs. Those symptoms include irritation, itching, burning, rash, abnormal discharge (not including gel), odor, or pain or difficulty in urination.
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Infections and infestations
Vulvovaginal mycotic infection
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4.2%
17/405 • Number of events 17 • 6 months, immediately after informed consent has been obtained and lasts through the study Exit Visit, up to 6 months.
For this study, an Adverse Event (AE) is defined as one following: 1) any genital or urinary tract problem that lasts more than an hour, 2) any non-genital/urinary tract problem that is at least possibly related to condom use, or 3) a serious adverse event. The transient symptoms associated with the use of the study condom will not be reported as AEs. Those symptoms include irritation, itching, burning, rash, abnormal discharge (not including gel), odor, or pain or difficulty in urination.
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Investigations
Smear cervix abnormal
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0.25%
1/405 • Number of events 1 • 6 months, immediately after informed consent has been obtained and lasts through the study Exit Visit, up to 6 months.
For this study, an Adverse Event (AE) is defined as one following: 1) any genital or urinary tract problem that lasts more than an hour, 2) any non-genital/urinary tract problem that is at least possibly related to condom use, or 3) a serious adverse event. The transient symptoms associated with the use of the study condom will not be reported as AEs. Those symptoms include irritation, itching, burning, rash, abnormal discharge (not including gel), odor, or pain or difficulty in urination.
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Nervous system disorders
Convulsion
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0.25%
1/405 • Number of events 1 • 6 months, immediately after informed consent has been obtained and lasts through the study Exit Visit, up to 6 months.
For this study, an Adverse Event (AE) is defined as one following: 1) any genital or urinary tract problem that lasts more than an hour, 2) any non-genital/urinary tract problem that is at least possibly related to condom use, or 3) a serious adverse event. The transient symptoms associated with the use of the study condom will not be reported as AEs. Those symptoms include irritation, itching, burning, rash, abnormal discharge (not including gel), odor, or pain or difficulty in urination.
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Renal and urinary disorders
Dysuria
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1.5%
6/405 • Number of events 6 • 6 months, immediately after informed consent has been obtained and lasts through the study Exit Visit, up to 6 months.
For this study, an Adverse Event (AE) is defined as one following: 1) any genital or urinary tract problem that lasts more than an hour, 2) any non-genital/urinary tract problem that is at least possibly related to condom use, or 3) a serious adverse event. The transient symptoms associated with the use of the study condom will not be reported as AEs. Those symptoms include irritation, itching, burning, rash, abnormal discharge (not including gel), odor, or pain or difficulty in urination.
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Renal and urinary disorders
Micturition urgency
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0.74%
3/405 • Number of events 3 • 6 months, immediately after informed consent has been obtained and lasts through the study Exit Visit, up to 6 months.
For this study, an Adverse Event (AE) is defined as one following: 1) any genital or urinary tract problem that lasts more than an hour, 2) any non-genital/urinary tract problem that is at least possibly related to condom use, or 3) a serious adverse event. The transient symptoms associated with the use of the study condom will not be reported as AEs. Those symptoms include irritation, itching, burning, rash, abnormal discharge (not including gel), odor, or pain or difficulty in urination.
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Renal and urinary disorders
Pollakiuria
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0.99%
4/405 • Number of events 4 • 6 months, immediately after informed consent has been obtained and lasts through the study Exit Visit, up to 6 months.
For this study, an Adverse Event (AE) is defined as one following: 1) any genital or urinary tract problem that lasts more than an hour, 2) any non-genital/urinary tract problem that is at least possibly related to condom use, or 3) a serious adverse event. The transient symptoms associated with the use of the study condom will not be reported as AEs. Those symptoms include irritation, itching, burning, rash, abnormal discharge (not including gel), odor, or pain or difficulty in urination.
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Renal and urinary disorders
Stress urinary incontinence
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0.25%
1/405 • Number of events 1 • 6 months, immediately after informed consent has been obtained and lasts through the study Exit Visit, up to 6 months.
For this study, an Adverse Event (AE) is defined as one following: 1) any genital or urinary tract problem that lasts more than an hour, 2) any non-genital/urinary tract problem that is at least possibly related to condom use, or 3) a serious adverse event. The transient symptoms associated with the use of the study condom will not be reported as AEs. Those symptoms include irritation, itching, burning, rash, abnormal discharge (not including gel), odor, or pain or difficulty in urination.
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Reproductive system and breast disorders
Bartholin's cyst
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0.25%
1/405 • Number of events 1 • 6 months, immediately after informed consent has been obtained and lasts through the study Exit Visit, up to 6 months.
For this study, an Adverse Event (AE) is defined as one following: 1) any genital or urinary tract problem that lasts more than an hour, 2) any non-genital/urinary tract problem that is at least possibly related to condom use, or 3) a serious adverse event. The transient symptoms associated with the use of the study condom will not be reported as AEs. Those symptoms include irritation, itching, burning, rash, abnormal discharge (not including gel), odor, or pain or difficulty in urination.
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Reproductive system and breast disorders
Dysmenorrhoea
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0.25%
1/405 • Number of events 1 • 6 months, immediately after informed consent has been obtained and lasts through the study Exit Visit, up to 6 months.
For this study, an Adverse Event (AE) is defined as one following: 1) any genital or urinary tract problem that lasts more than an hour, 2) any non-genital/urinary tract problem that is at least possibly related to condom use, or 3) a serious adverse event. The transient symptoms associated with the use of the study condom will not be reported as AEs. Those symptoms include irritation, itching, burning, rash, abnormal discharge (not including gel), odor, or pain or difficulty in urination.
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Reproductive system and breast disorders
Dyspareunia
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0.49%
2/405 • Number of events 2 • 6 months, immediately after informed consent has been obtained and lasts through the study Exit Visit, up to 6 months.
For this study, an Adverse Event (AE) is defined as one following: 1) any genital or urinary tract problem that lasts more than an hour, 2) any non-genital/urinary tract problem that is at least possibly related to condom use, or 3) a serious adverse event. The transient symptoms associated with the use of the study condom will not be reported as AEs. Those symptoms include irritation, itching, burning, rash, abnormal discharge (not including gel), odor, or pain or difficulty in urination.
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Reproductive system and breast disorders
Genital pain
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0.25%
1/405 • Number of events 1 • 6 months, immediately after informed consent has been obtained and lasts through the study Exit Visit, up to 6 months.
For this study, an Adverse Event (AE) is defined as one following: 1) any genital or urinary tract problem that lasts more than an hour, 2) any non-genital/urinary tract problem that is at least possibly related to condom use, or 3) a serious adverse event. The transient symptoms associated with the use of the study condom will not be reported as AEs. Those symptoms include irritation, itching, burning, rash, abnormal discharge (not including gel), odor, or pain or difficulty in urination.
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Reproductive system and breast disorders
Menorrhagia
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0.25%
1/405 • Number of events 1 • 6 months, immediately after informed consent has been obtained and lasts through the study Exit Visit, up to 6 months.
For this study, an Adverse Event (AE) is defined as one following: 1) any genital or urinary tract problem that lasts more than an hour, 2) any non-genital/urinary tract problem that is at least possibly related to condom use, or 3) a serious adverse event. The transient symptoms associated with the use of the study condom will not be reported as AEs. Those symptoms include irritation, itching, burning, rash, abnormal discharge (not including gel), odor, or pain or difficulty in urination.
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Reproductive system and breast disorders
Metrorrhagia
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1.5%
6/405 • Number of events 6 • 6 months, immediately after informed consent has been obtained and lasts through the study Exit Visit, up to 6 months.
For this study, an Adverse Event (AE) is defined as one following: 1) any genital or urinary tract problem that lasts more than an hour, 2) any non-genital/urinary tract problem that is at least possibly related to condom use, or 3) a serious adverse event. The transient symptoms associated with the use of the study condom will not be reported as AEs. Those symptoms include irritation, itching, burning, rash, abnormal discharge (not including gel), odor, or pain or difficulty in urination.
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Reproductive system and breast disorders
Oedema genital
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0.25%
1/405 • Number of events 1 • 6 months, immediately after informed consent has been obtained and lasts through the study Exit Visit, up to 6 months.
For this study, an Adverse Event (AE) is defined as one following: 1) any genital or urinary tract problem that lasts more than an hour, 2) any non-genital/urinary tract problem that is at least possibly related to condom use, or 3) a serious adverse event. The transient symptoms associated with the use of the study condom will not be reported as AEs. Those symptoms include irritation, itching, burning, rash, abnormal discharge (not including gel), odor, or pain or difficulty in urination.
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Reproductive system and breast disorders
Pelvic pain
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0.49%
2/405 • Number of events 2 • 6 months, immediately after informed consent has been obtained and lasts through the study Exit Visit, up to 6 months.
For this study, an Adverse Event (AE) is defined as one following: 1) any genital or urinary tract problem that lasts more than an hour, 2) any non-genital/urinary tract problem that is at least possibly related to condom use, or 3) a serious adverse event. The transient symptoms associated with the use of the study condom will not be reported as AEs. Those symptoms include irritation, itching, burning, rash, abnormal discharge (not including gel), odor, or pain or difficulty in urination.
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Reproductive system and breast disorders
Vaginal discharge
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1.7%
7/405 • Number of events 7 • 6 months, immediately after informed consent has been obtained and lasts through the study Exit Visit, up to 6 months.
For this study, an Adverse Event (AE) is defined as one following: 1) any genital or urinary tract problem that lasts more than an hour, 2) any non-genital/urinary tract problem that is at least possibly related to condom use, or 3) a serious adverse event. The transient symptoms associated with the use of the study condom will not be reported as AEs. Those symptoms include irritation, itching, burning, rash, abnormal discharge (not including gel), odor, or pain or difficulty in urination.
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Reproductive system and breast disorders
Vaginal disorder
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0.25%
1/405 • Number of events 1 • 6 months, immediately after informed consent has been obtained and lasts through the study Exit Visit, up to 6 months.
For this study, an Adverse Event (AE) is defined as one following: 1) any genital or urinary tract problem that lasts more than an hour, 2) any non-genital/urinary tract problem that is at least possibly related to condom use, or 3) a serious adverse event. The transient symptoms associated with the use of the study condom will not be reported as AEs. Those symptoms include irritation, itching, burning, rash, abnormal discharge (not including gel), odor, or pain or difficulty in urination.
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Reproductive system and breast disorders
Vaginal haemorrhage
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0.49%
2/405 • Number of events 2 • 6 months, immediately after informed consent has been obtained and lasts through the study Exit Visit, up to 6 months.
For this study, an Adverse Event (AE) is defined as one following: 1) any genital or urinary tract problem that lasts more than an hour, 2) any non-genital/urinary tract problem that is at least possibly related to condom use, or 3) a serious adverse event. The transient symptoms associated with the use of the study condom will not be reported as AEs. Those symptoms include irritation, itching, burning, rash, abnormal discharge (not including gel), odor, or pain or difficulty in urination.
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Reproductive system and breast disorders
Vaginal odour
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1.2%
5/405 • Number of events 5 • 6 months, immediately after informed consent has been obtained and lasts through the study Exit Visit, up to 6 months.
For this study, an Adverse Event (AE) is defined as one following: 1) any genital or urinary tract problem that lasts more than an hour, 2) any non-genital/urinary tract problem that is at least possibly related to condom use, or 3) a serious adverse event. The transient symptoms associated with the use of the study condom will not be reported as AEs. Those symptoms include irritation, itching, burning, rash, abnormal discharge (not including gel), odor, or pain or difficulty in urination.
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Reproductive system and breast disorders
Vaginal swelling
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0.25%
1/405 • Number of events 1 • 6 months, immediately after informed consent has been obtained and lasts through the study Exit Visit, up to 6 months.
For this study, an Adverse Event (AE) is defined as one following: 1) any genital or urinary tract problem that lasts more than an hour, 2) any non-genital/urinary tract problem that is at least possibly related to condom use, or 3) a serious adverse event. The transient symptoms associated with the use of the study condom will not be reported as AEs. Those symptoms include irritation, itching, burning, rash, abnormal discharge (not including gel), odor, or pain or difficulty in urination.
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Reproductive system and breast disorders
Vulval disorder
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0.49%
2/405 • Number of events 2 • 6 months, immediately after informed consent has been obtained and lasts through the study Exit Visit, up to 6 months.
For this study, an Adverse Event (AE) is defined as one following: 1) any genital or urinary tract problem that lasts more than an hour, 2) any non-genital/urinary tract problem that is at least possibly related to condom use, or 3) a serious adverse event. The transient symptoms associated with the use of the study condom will not be reported as AEs. Those symptoms include irritation, itching, burning, rash, abnormal discharge (not including gel), odor, or pain or difficulty in urination.
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Reproductive system and breast disorders
Vulvovaginal burning sensation
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1.7%
7/405 • Number of events 7 • 6 months, immediately after informed consent has been obtained and lasts through the study Exit Visit, up to 6 months.
For this study, an Adverse Event (AE) is defined as one following: 1) any genital or urinary tract problem that lasts more than an hour, 2) any non-genital/urinary tract problem that is at least possibly related to condom use, or 3) a serious adverse event. The transient symptoms associated with the use of the study condom will not be reported as AEs. Those symptoms include irritation, itching, burning, rash, abnormal discharge (not including gel), odor, or pain or difficulty in urination.
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Reproductive system and breast disorders
Vulvovaginal discomfort
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4.7%
19/405 • Number of events 19 • 6 months, immediately after informed consent has been obtained and lasts through the study Exit Visit, up to 6 months.
For this study, an Adverse Event (AE) is defined as one following: 1) any genital or urinary tract problem that lasts more than an hour, 2) any non-genital/urinary tract problem that is at least possibly related to condom use, or 3) a serious adverse event. The transient symptoms associated with the use of the study condom will not be reported as AEs. Those symptoms include irritation, itching, burning, rash, abnormal discharge (not including gel), odor, or pain or difficulty in urination.
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Reproductive system and breast disorders
Vulvovaginal dryness
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0.25%
1/405 • Number of events 1 • 6 months, immediately after informed consent has been obtained and lasts through the study Exit Visit, up to 6 months.
For this study, an Adverse Event (AE) is defined as one following: 1) any genital or urinary tract problem that lasts more than an hour, 2) any non-genital/urinary tract problem that is at least possibly related to condom use, or 3) a serious adverse event. The transient symptoms associated with the use of the study condom will not be reported as AEs. Those symptoms include irritation, itching, burning, rash, abnormal discharge (not including gel), odor, or pain or difficulty in urination.
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Reproductive system and breast disorders
Vulvovaginal pruritus
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3.0%
12/405 • Number of events 12 • 6 months, immediately after informed consent has been obtained and lasts through the study Exit Visit, up to 6 months.
For this study, an Adverse Event (AE) is defined as one following: 1) any genital or urinary tract problem that lasts more than an hour, 2) any non-genital/urinary tract problem that is at least possibly related to condom use, or 3) a serious adverse event. The transient symptoms associated with the use of the study condom will not be reported as AEs. Those symptoms include irritation, itching, burning, rash, abnormal discharge (not including gel), odor, or pain or difficulty in urination.
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Skin and subcutaneous tissue disorders
Rash
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0.49%
2/405 • Number of events 2 • 6 months, immediately after informed consent has been obtained and lasts through the study Exit Visit, up to 6 months.
For this study, an Adverse Event (AE) is defined as one following: 1) any genital or urinary tract problem that lasts more than an hour, 2) any non-genital/urinary tract problem that is at least possibly related to condom use, or 3) a serious adverse event. The transient symptoms associated with the use of the study condom will not be reported as AEs. Those symptoms include irritation, itching, burning, rash, abnormal discharge (not including gel), odor, or pain or difficulty in urination.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place