Trial Outcomes & Findings for Clinical Performance of a Vaginal Pessary (pHyph) in Bacterial Vaginosis (NCT NCT03762083)
NCT ID: NCT03762083
Last Updated: 2025-07-25
Results Overview
Defined as absence of all of the following 3 Amsel criteria: 1. Thin, white, yellow, homogenous discharge 2. Clue cells on microscopy (more than 20% of epithelial cells) 3. Release of fishy odor "i.e. a positive whiff test" when alkali (10% potassium hydroxide \[KOH\] solution) is added
COMPLETED
NA
24 participants
Day 7
2025-07-25
Participant Flow
Participant milestones
| Measure |
pHyph, Gedea Pessary
Clinical performance, tolerability, safety and user experience of Gedea Pessary, a slow-release vaginal tablet for the treatment of bacterial vaginosis (BV).
pHyph, Gedea pessary: pHyph is a vaginal tablet for the treatment of BV.
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|---|---|
|
Overall Study
STARTED
|
24
|
|
Overall Study
COMPLETED
|
21
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
pHyph, Gedea Pessary
Clinical performance, tolerability, safety and user experience of Gedea Pessary, a slow-release vaginal tablet for the treatment of bacterial vaginosis (BV).
pHyph, Gedea pessary: pHyph is a vaginal tablet for the treatment of BV.
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|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
pHyph, Gedea Pessary
n=24 Participants
Clinical performance, tolerability, safety and user experience of Gedea Pessary, a slow-release vaginal tablet for the treatment of BV.
pHyph, Gedea pessary: pHyph is a vaginal tablet for the treatment of BV.
|
|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=24 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=24 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=24 Participants
|
|
Age, Continuous
|
33.1 years
STANDARD_DEVIATION 8.8 • n=24 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=24 Participants
|
|
Region of Enrollment
Sweden
|
24 Participants
n=24 Participants
|
|
Experience any bacterial vaginosis (BV) infection during the last 12 months
Yes
|
16 Participants
n=24 Participants
|
|
Experience any bacterial vaginosis (BV) infection during the last 12 months
No
|
8 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Day 7Population: Number of patients included in analysis = 22.
Defined as absence of all of the following 3 Amsel criteria: 1. Thin, white, yellow, homogenous discharge 2. Clue cells on microscopy (more than 20% of epithelial cells) 3. Release of fishy odor "i.e. a positive whiff test" when alkali (10% potassium hydroxide \[KOH\] solution) is added
Outcome measures
| Measure |
pHyph, Gedea Pessary
n=22 Participants
Clinical performance, tolerability, safety and user experience of Gedea Pessary, a slow-release vaginal tablet for the treatment of bacterial vaginosis (BV).
pHyph, Gedea pessary: pHyph is a vaginal tablet for the treatment of BV.
|
|---|---|
|
Clinical Cure Rate
|
18 Participants
|
SECONDARY outcome
Timeframe: Day 7 compared to Day 0Population: Statistical analysis of proportion of patients being negative for Amsel criterion 1 (discharge) on Day 7 compared to Day 0. Number of patients included in analysis =21.
Defined as absence of one of the following Amsel criteria: 1. Thin, white, yellow, homogenous discharge 2. Clue cells on microscopy (more than 20% of epithelial cells) 3. Release of fishy odor "i.e. a positive whiff test" when alkali (10% potassium hydroxide \[KOH\] solution) is added
Outcome measures
| Measure |
pHyph, Gedea Pessary
n=21 Participants
Clinical performance, tolerability, safety and user experience of Gedea Pessary, a slow-release vaginal tablet for the treatment of bacterial vaginosis (BV).
pHyph, Gedea pessary: pHyph is a vaginal tablet for the treatment of BV.
|
|---|---|
|
Proportion of Patients Being Negative for Each of the 3 Amsel Criteria - Criterion 1
|
18 Participants
|
SECONDARY outcome
Timeframe: Day 7 compared to Day 0Population: Statistical analysis of proportion of patients being negative for Amsel criterion 2 (clue cells) on Day 7 compared to Day 0. Number of patients included in analysis = 20.
Defined as absence of one of the following Amsel criteria: 1. Thin, white, yellow, homogenous discharge 2. Clue cells on microscopy (more than 20% of epithelial cells) 3. Release of fishy odor "i.e. a positive whiff test" when alkali (10% potassium hydroxide \[KOH\] solution is added
Outcome measures
| Measure |
pHyph, Gedea Pessary
n=20 Participants
Clinical performance, tolerability, safety and user experience of Gedea Pessary, a slow-release vaginal tablet for the treatment of bacterial vaginosis (BV).
pHyph, Gedea pessary: pHyph is a vaginal tablet for the treatment of BV.
|
|---|---|
|
Proportion of Patients Being Negative for Each of the 3 Amsel Criteria - Criterion 2
|
18 Participants
|
SECONDARY outcome
Timeframe: Day 7 compared to Day 0Population: Statistical analysis of proportion of patients being negative for Amsel criterion 3 (fishy odour) on Day 7 compared to Day 0. Number of participants included in the analysis = 22.
Defined as absence of one of the following Amsel criteria: 1. Thin, white, yellow, homogenous discharge 2. Clue cells on microscopy (more than 20% of epithelial cells) 3. Release of fishy odour "i.e. a positive whiff test" when alkali (10% potassium hydroxide \[KOH\] solution) is added
Outcome measures
| Measure |
pHyph, Gedea Pessary
n=22 Participants
Clinical performance, tolerability, safety and user experience of Gedea Pessary, a slow-release vaginal tablet for the treatment of bacterial vaginosis (BV).
pHyph, Gedea pessary: pHyph is a vaginal tablet for the treatment of BV.
|
|---|---|
|
Proportion of Patients Being Negative for Each of the 3 Amsel Criteria - Criterion 3
|
19 Participants
|
SECONDARY outcome
Timeframe: Day 7Population: The Full analysis set population contained 24 patients. 2 patients were not included in this analysis due to missing data.
General assessment of the treatment on a integer scale that ranges from 1 to 10. The lower end of the scale is indicated with the term "Not satisfied" and the higher end with the term "Very satisfied". Question asked: How do you generally regard the treatment?
Outcome measures
| Measure |
pHyph, Gedea Pessary
n=22 Participants
Clinical performance, tolerability, safety and user experience of Gedea Pessary, a slow-release vaginal tablet for the treatment of bacterial vaginosis (BV).
pHyph, Gedea pessary: pHyph is a vaginal tablet for the treatment of BV.
|
|---|---|
|
Usability, Measured by Patient Questionnaire
|
7.1 Integer scale (1-10)
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: Up to Day 35Population: The Full analysis set population contained 24 patients.The sub-set of the Full analysis set including patients not receiving prolonged treatment contained 18 patients. Of these, 18 patients were included in this analysis of recurrence at Day 14 and 16 patients were included in the analysis of recurrence at Day 35.
Proportion of patients answering Yes to the question "Have the symptoms recurred?"
Outcome measures
| Measure |
pHyph, Gedea Pessary
n=18 Participants
Clinical performance, tolerability, safety and user experience of Gedea Pessary, a slow-release vaginal tablet for the treatment of bacterial vaginosis (BV).
pHyph, Gedea pessary: pHyph is a vaginal tablet for the treatment of BV.
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|---|---|
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Proportion of Patients Having a Recurrence of the BV
Day 14
|
1 Participants
|
|
Proportion of Patients Having a Recurrence of the BV
Day 35
|
0 Participants
|
Adverse Events
pHyph, Gedea Pessary
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
pHyph, Gedea Pessary
n=24 participants at risk
Clinical performance, tolerability, safety and user experience of Gedea Pessary, a slow-release vaginal tablet for the treatment of bacterial vaginosis (BV).
pHyph, Gedea pessary: pHyph is a vaginal tablet for the treatment of BV.
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|---|---|
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Nervous system disorders
Headache
|
41.7%
10/24 • Number of events 13 • Up to day 42.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
12.5%
3/24 • Number of events 3 • Up to day 42.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place