Trial Outcomes & Findings for Ospemifene vs. Conjugated Estrogens in the Treatment of Postmenopausal Sexual Dysfunction (NCT NCT03018106)
NCT ID: NCT03018106
Last Updated: 2018-01-23
Results Overview
The Female Sexual Function Index (FSFI) is a 19 item questionnaire that asks about sexual function in the prior four weeks. The FSFI was developed for the specific purpose of assessing sexual arousal, orgasm, satisfaction, pain related to sexual functioning in clinical trial participants. Participants answer by selecting between 5-6 question-specific options to rate the degree to which the question fits their experience. Each response option is assigned a point and each question has 0-5 or 1-5 possible points. The points are summed to determine a total score. The total score can range from 2 to 36 and scores equal to or less than 26.55 indicate female sexual dysfunction (FSD).
TERMINATED
PHASE4
1 participants
Baseline, Week 12
2018-01-23
Participant Flow
Participants were enrolled between June 2017 and September 2017
One individual gave informed consent to participate in the study and was randomized to the Estrogen arm.
Participant milestones
| Measure |
Ospemifene
Women randomized to this arm were to receive 60mg oral ospemifene, taken daily, for 12 weeks
|
Estrogen
Women randomized to this arm were to receive 0.5mg vaginal conjugated estrogens, placed vaginally twice per week, for 12 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
0
|
1
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Ospemifene
Women randomized to this arm were to receive 60mg oral ospemifene, taken daily, for 12 weeks
|
Estrogen
Women randomized to this arm were to receive 0.5mg vaginal conjugated estrogens, placed vaginally twice per week, for 12 weeks
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Ospemifene vs. Conjugated Estrogens in the Treatment of Postmenopausal Sexual Dysfunction
Baseline characteristics by cohort
| Measure |
Ospemifene
Women randomized to this arm were to receive 60mg oral ospemifene, taken daily, for 12 weeks
|
Estrogen
n=1 Participants
Women randomized to this arm were to receive 0.5mg vaginal conjugated estrogens, placed vaginally twice per week, for 12 weeks
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
—
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
—
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
—
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
—
|
51 years
STANDARD_DEVIATION 0.0 • n=107 Participants
|
51 years
STANDARD_DEVIATION 0.0 • n=206 Participants
|
|
Sex: Female, Male
Female
|
—
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
—
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
—
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
—
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
—
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
—
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
—
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
—
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
—
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
—
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
—
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
—
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
—
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: The single participant was lost to follow up prior to completing the Week 12 assessment.
The Female Sexual Function Index (FSFI) is a 19 item questionnaire that asks about sexual function in the prior four weeks. The FSFI was developed for the specific purpose of assessing sexual arousal, orgasm, satisfaction, pain related to sexual functioning in clinical trial participants. Participants answer by selecting between 5-6 question-specific options to rate the degree to which the question fits their experience. Each response option is assigned a point and each question has 0-5 or 1-5 possible points. The points are summed to determine a total score. The total score can range from 2 to 36 and scores equal to or less than 26.55 indicate female sexual dysfunction (FSD).
Outcome measures
| Measure |
Estrogen
n=1 Participants
Women randomized to this arm received 0.5mg vaginal conjugated estrogens, placed vaginally twice per week, for 12 weeks
|
|---|---|
|
Female Sexual Function Index Score
Baseline
|
9 units on a scale
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: The single participant was lost to follow up prior to completing the Week 12 assessment.
Participants reported pain with sex at the Baseline Visit and after 12 weeks of treatment. Participants rated the severity of their symptoms from 0 to 3, where 0 = none, 1 = mild, 2 = moderate and 3 = severe.
Outcome measures
| Measure |
Estrogen
n=1 Participants
Women randomized to this arm received 0.5mg vaginal conjugated estrogens, placed vaginally twice per week, for 12 weeks
|
|---|---|
|
Pain With Sex
Baseline
|
2 units on a scale
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: The single participant was lost to follow up prior to completing the Week 12 assessment.
Participants reported vaginal dryness at the Baseline Visit and after 12 weeks of treatment. Participants rated the severity of their symptoms from 0 to 3, where 0 = none, 1 = mild, 2 = moderate and 3 = severe.
Outcome measures
| Measure |
Estrogen
n=1 Participants
Women randomized to this arm received 0.5mg vaginal conjugated estrogens, placed vaginally twice per week, for 12 weeks
|
|---|---|
|
Vaginal Dryness
Baseline
|
3 units on a scale
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: The single participant was lost to follow up prior to completing the Week 12 assessment.
Participants reported vaginal itching at the Baseline Visit and after 12 weeks of treatment. Participants rated the severity of their symptoms from 0 to 3, where 0 = none, 1 = mild, 2 = moderate and 3 = severe.
Outcome measures
| Measure |
Estrogen
n=1 Participants
Women randomized to this arm received 0.5mg vaginal conjugated estrogens, placed vaginally twice per week, for 12 weeks
|
|---|---|
|
Vaginal Itching
Baseline
|
3 units on a scale
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: The single participant was lost to follow up prior to completing the Week 12 assessment.
Participants reported vaginal irritation at the Baseline Visit and after 12 weeks of treatment. Participants rated the severity of their symptoms from 0 to 3, where 0 = none, 1 = mild, 2 = moderate and 3 = severe.
Outcome measures
| Measure |
Estrogen
n=1 Participants
Women randomized to this arm received 0.5mg vaginal conjugated estrogens, placed vaginally twice per week, for 12 weeks
|
|---|---|
|
Vaginal Irritation
Baseline
|
3 units on a scale
|
Adverse Events
Estrogen
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place