Trial · NCT01306331
Study of Contraceptive Efficacy & Safety of Phexxi™ (Previously Known as Amphora) Gel Compared to Conceptrol Vaginal Gel
NCT01306331, Phase 3, Completed, Evofem Inc.; results first posted 2020-07-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Contraceptive Efficacy & Safety of Phexxi™ (Previously Known as Amphora) Gel Compared to Conceptrol Vaginal Gel. Trials, record NCT01306331. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01306331
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Contraceptive Efficacy & Safety of Phexxi™ (Previously Known as Amphora) Gel Compared to Conceptrol Vaginal Gel
- NCT number
- NCT01306331
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 3,389 participants, actual
- Lead sponsor
- Evofem Inc.
- Conditions
- Contraception
- Interventions
- Conceptrol, Amphora
- First posted
- 2011-03-01
- Last updated
- 2022-07-12
- Results first posted
- 2020-07-30
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 6-Month (183 Days) Cumulative Pregnancy Percentage | 183 days | The primary endpoint was the evaluation of contraceptive efficacy over six months (183 days) of Amphora™ Gel use when compared to Conceptrol® Vaginal Gel. Kaplan-Meier methods were used to estimate the six-month cumulative pregnancy percentage of women in the MITT population by treatment group |
| Secondary | 6-Month (183 Days) Cumulative Pregnancy Percentage for Subjects With Perfect Use | 183 days | Perfect use contraceptive efficacy over six months (183 days) of Amphora™ Gel use when compared to Conceptrol® Vaginal Gel. Kaplan-Meier methods were used to estimate the six-month cumulative pregnancy percentage of women in the efficacy evaluable (EE) population by treatment group |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 6-Month (183 Days) Cumulative Pregnancy Percentage | 183 days | mITT Population - ITT subjects whose diaries indicated they had at least one episode of coitus while using the assigned study product (also referred as Typical-Use), between 18 to 35 years of age (inclusive) at enrollment, had at least 1 cycle without any backup contraception or EC, and for whom there was at least one report of pregnancy status. | pregnancy percentage | MEAN |
| SECONDARY | 6-Month (183 Days) Cumulative Pregnancy Percentage for Subjects With Perfect Use | 183 days | EE populations - a subset of the MITT population that includes only subjects with at least one EE cycle, where an EE cycle is a cycle where the diaries indicated they used the product correctly for every act of intercourse in the cycle. | pregnancy percentage | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 6-Month (183 Days) Cumulative Pregnancy Percentage | Conceptrol | 10.0 | 95% Confidence Interval 8.1 to 11.9 | pregnancy percentage | |
| 6-Month (183 Days) Cumulative Pregnancy Percentage | Amphora | 10.5 | 95% Confidence Interval 8.6 to 12.3 | pregnancy percentage | |
| 6-Month (183 Days) Cumulative Pregnancy Percentage for Subjects With Perfect Use | Conceptrol | 4.2 | 95% Confidence Interval 2.8 to 5.6 | pregnancy percentage | |
| 6-Month (183 Days) Cumulative Pregnancy Percentage for Subjects With Perfect Use | Amphora | 4.1 | 95% Confidence Interval 2.7 to 5.4 | pregnancy percentage |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Conceptrol | 1,659 | |
| Overall Study | STARTED | Amphora | 1,665 | |
| Overall Study | COMPLETED | Conceptrol | 758 | |
| Overall Study | COMPLETED | Amphora | 788 | |
| Overall Study | NOT COMPLETED | Conceptrol | 901 | |
| Overall Study | NOT COMPLETED | Amphora | 877 |
Source ClinicalTrials.gov
Adverse events74
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Urinary Tract Infection | Infections and infestations | Conceptrol | 193 | 1,477 | |
| other | Urinary Tract Infection | Infections and infestations | Amphora | 140 | 1,458 | |
| other | Vaginitis Bacterial | Infections and infestations | Conceptrol | 170 | 1,477 | |
| other | Vaginitis Bacterial | Infections and infestations | Amphora | 160 | 1,458 | |
| other | Vulvovaginal Mycotic | Infections and infestations | Conceptrol | 168 | 1,477 | |
| other | Vulvovaginal Mycotic | Infections and infestations | Amphora | 156 | 1,458 | |
| other | Headache | Nervous system disorders | Conceptrol | 80 | 1,477 | |
| other | Headache | Nervous system disorders | Amphora | 96 | 1,458 | |
| other | Vulvovaginal Pruritus | Reproductive system and breast disorders | Conceptrol | 76 | 1,477 | |
| other | Vulvovaginal Pruritus | Reproductive system and breast disorders | Amphora | 55 | 1,458 |
1 to 10 of 74Source ClinicalTrials.gov
See all 74 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Conceptrol | 0 | 1,477 |
| Total, all-cause mortality | Amphora | 0 | 1,458 |
| Total, other adverse events | Conceptrol | 857 | 1,477 |
| Total, other adverse events | Amphora | 793 | 1,458 |
| Total, serious adverse events | Conceptrol | 19 | 1,477 |
| Total, serious adverse events | Amphora | 11 | 1,458 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Conceptrol vs Amphora: deaths from any cause | Trial comparisons |
| Conceptrol vs Amphora: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01306331
GET https://conductscience.org/api/trials/v1/NCT01306331/events?page=2