Trial · NCT00274261

Study of the Safety and Contraceptive Efficacy of C31G Compared to Conceptrol®

NCT00274261, Phase 3, Completed, Premier Research; results first posted 2013-06-06

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study of the Safety and Contraceptive Efficacy of C31G Compared to Conceptrol®. Trials, record NCT00274261. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00274261

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study of the Safety and Contraceptive Efficacy of C31G Compared to Conceptrol®
NCT number: NCT00274261
Status: Completed
Phases: Phase 3
Enrollment: 1,565 participants, actual
Lead sponsor: Premier Research
Conditions: Pregnancy
Interventions: C31G, nonoxynol-9 (N-9)
First posted: 2006-01-10
Last updated: 2018-05-01
Results first posted: 2013-06-06

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	The Cumulative Probability of Typical-use 6 Month (183 Days) Pregnancy.	6 months	Number of pregnancies in women using C31G gel for 6 months (183 days) compared to women using Conceptrol gel for the same time frame.
Secondary	Incidence of Adverse Events.	duration of the study - through 6 month or 12 months of use	Evaluated by comparing the incidence of Adverse Events (AEs) among subjects using their assigned treatment for at least one day.

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	The Cumulative Probability of Typical-use 6 Month (183 Days) Pregnancy.	6 months	Modified Intent-To-Treat (MITT): ITT subjects whose diaries indicated they had at least one episode of coitus while using the assigned study product (also referred as Typical-Use) and for whom there is at least one report of pregnancy status.	6 month probability of pregnancy	NUMBER
SECONDARY	Incidence of Adverse Events.	duration of the study - through 6 month or 12 months of use		Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
The Cumulative Probability of Typical-use 6 Month (183 Days) Pregnancy.	C31G	0.12	95% Confidence Interval 0.093 to 0.147	6 month probability of pregnancy
The Cumulative Probability of Typical-use 6 Month (183 Days) Pregnancy.	Conceptrol	0.12	95% Confidence Interval 0.087 to 0.153	6 month probability of pregnancy
Incidence of Adverse Events.	C31G Vaginal Gel	617		Participants
Incidence of Adverse Events.	Conceptrol® Vaginal Gel	434		Participants

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	C31G	932
Overall Study	STARTED	Conceptrol	633
Overall Study	COMPLETED	C31G	443
Overall Study	COMPLETED	Conceptrol	296
Overall Study	NOT COMPLETED	C31G	489
Overall Study	NOT COMPLETED	Conceptrol	337

Source ClinicalTrials.gov

Adverse events100

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
other	Nasopharygitis	Infections and infestations	C31G	130	836
other	Nasopharygitis	Infections and infestations	Conceptrol	92	560
other	Vaginitis bacterial	Infections and infestations	C31G	100	836
other	Vaginitis bacterial	Infections and infestations	Conceptrol	73	560
other	Vaginal mycosis	Infections and infestations	C31G	87	836
other	Vaginal mycosis	Infections and infestations	Conceptrol	70	560
other	Headache	Nervous system disorders	C31G	79	836
other	Headache	Nervous system disorders	Conceptrol	63	560
other	Urinary tract infection	Infections and infestations	C31G	79	836
other	Urinary tract infection	Infections and infestations	Conceptrol	59	560

1 to 10 of 100Source ClinicalTrials.gov

See all 100 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	C31G
Total, all-cause mortality	Conceptrol
Total, other adverse events	C31G	617	836
Total, other adverse events	Conceptrol	434	560
Total, serious adverse events	C31G	10	836
Total, serious adverse events	Conceptrol	12	560

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
21099590	DERIVED

Source PubMed

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
C31G Vaginal Gel vs Conceptrol® Vaginal Gel: Incidence of Adverse Events.	Trial comparisons
C31G vs Conceptrol: 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT00274261

GET https://conductscience.org/api/trials/v1/NCT00274261/events?page=2

API reference For AI assistants