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

NCT00274261 | Completed Phase 3 Results DMC

• 2 other identifiers: CCN004HHSN2752004033661
• Study Type: interventional
• Target: 1,565
• Locations: 1 country
• Sites: 15

Brief Summary

This is a multicenter, randomized, double-masked, controlled, phase III study of repeated use of C31G vaginal gel compared to Conceptrol® Vaginal Gel as the primary method of contraception over six months (183 days) and at least six cycles of use. In addition, there is an opportunity for subjects to continue with study treatment for up to twelve months (365 days) and twelve cycles of treatment upon completion of the first six months of treatment.

Conditions

Pregnancy

Keywords

contraception

Outcome Measures

Primary Outcomes (1)

• The Cumulative Probability of Typical-use 6 Month (183 Days) Pregnancy.

  Number of pregnancies in women using C31G gel for 6 months (183 days) compared to women using Conceptrol gel for the same time frame.

  6 months

Secondary Outcomes (1)

• Incidence of Adverse Events.

  duration of the study - through 6 month or 12 months of use

Study Arms (2)

A

EXPERIMENTAL

C31G vaginal gel contains 35mg (1% concentration) of C31G in 3.5 mL volume of gel

Drug: C31G

B

ACTIVE COMPARATOR

Conceptrol® Vaginal gel contains 100mg (4% concentration) of nonoxynol-9 (N-9) in 2.5 mL volume of gel.

Drug: nonoxynol-9 (N-9)

Interventions

C31G DRUG

The subject will insert one applicator of C31G prior to each episode of vaginal intercourse during her participation in the study.

A

nonoxynol-9 (N-9) DRUG

The subject will insert one applicator of Conceptrol® vaginal gel (nonoxynol-9) prior to each episode of vaginal intercourse during her participation in the study.

B

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Potential subjects must:
• Be healthy women, who are sexually active, at risk for pregnancy and desiring contraception.
• Be within the age range of 18 through 40 years inclusive.
• Be at low-risk for human immunodeficiency virus (HIV) or sexually transmitted disease (STD) infection and currently have a single sex partner (minimum 4 months) who is also at low-risk for HIV or STD.
• Have a negative urine pregnancy test prior to enrollment.
• Have normal cyclic menses with a usual length of 24 to 35 days over the last 2 cycles or at least one spontaneous, normal menstrual cycle (2 menses) since delivery, abortion, or after discontinuing hormonal contraception/hormonal therapy.
• Be willing to accept a risk of pregnancy.
• Be willing to engage in at least 4 acts of heterosexual vaginal intercourse per month for a period of 6 months.
• Be willing to be randomized to either study treatment.
• Be willing to only use the study product as the primary method of contraception over the course of the study with the exception of emergency contraception (EC), when indicated.
• Be capable of using the study product properly and agree to observe all study directions and requirements.
• Be willing to keep a diary to record coital information, product use information, information about the use of other vaginal products, and sign and symptom data of subject and partner.
• Agree not to participate in any other clinical trials during the course of the study.
• Be willing to give written informed consent to participate in the trial.

You may not qualify if:

• Potential subjects must not:
• Have a history of allergy or sensitivity to spermicides or products containing N-9.
• Have had 3 or more urinary tract infections (UTI) in the past year.
• Have UTI by urine culture or symptomatic yeast vaginitis or symptomatic bacterial vaginosis diagnosed by wet mount unless treated and proof of cure is documented.
• Be pregnant, have a suspected pregnancy or desire to become pregnant during the course of the study.
• Have a history of infertility or of conditions that may lead to infertility, without subsequent intrauterine pregnancy.
• Have any contraindications to pregnancy (medical condition) or chronic use of category D or X medications.
• Have had more than one sexual partner in the last 4 months.
• Have shared injection drug needles within the past 12 months.
• Have or have been suspected to have HIV infection.
• Have been diagnosed with genital herpes simplex virus (HSV), with the first occurrence (initial episode) within three months prior to screening.
• Have 3 or more outbreaks of HSV within the last year.
• Have been diagnosed with any other STDs (including trichomonas) in the 6 months prior to the screening visit (with the exception of Human Papilloma Virus \[HPV\]).
• Be lactating or breastfeeding.
• Have any clinically significant abnormal vaginal bleeding or spotting within the month prior to screening.

Sponsors & Collaborators

• Premier Research: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (15)

California Family Health Council

Berkeley, California, 94710, United States

Location

California Family Health Council

Los Angeles, California, 90010, United States

Location

University of Colorado - Advanced reproductive Medicine

Aurora, Colorado, 80010, United States

Location

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

Bay State Medical Center

Springfield, Massachusetts, 01199, United States

Location

New York University

New York, New York, 10016, United States

Location

Columbia University

New York, New York, 10032, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

University Hospitals of Cleveland MacDonald Women's Hospital

Cleveland, Ohio, 44106, United States

Location

The Ohio State University College of Medicine

Columbus, Ohio, 43210, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

University of Pennsylvania Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

U.T. Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Jones Institute of Reproductive Medicine, EVMS

Norfolk, Virginia, 23507, United States

Location

Related Publications (1)

• Burke AE, Barnhart K, Jensen JT, Creinin MD, Walsh TL, Wan LS, Westhoff C, Thomas M, Archer D, Wu H, Liu J, Schlaff W, Carr BR, Blithe D. Contraceptive efficacy, acceptability, and safety of C31G and nonoxynol-9 spermicidal gels: a randomized controlled trial. Obstet Gynecol. 2010 Dec;116(6):1265-1273. doi: 10.1097/AOG.0b013e3181fc3b1a.

  PMID: 21099590 DERIVED

MeSH Terms

Interventions

C 31G; Nonoxynol

Intervention Hierarchy (Ancestors)

Polyethylene Glycols; Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Jason Woo, MD, MPH
• Organization: NICHD

woojj@mail.nih.gov

301-496-1662

Study Officials

• Diana L Blithe, Ph.D.

  Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2006
• First Posted: January 10, 2006
• Study Start: June 1, 2004
• Primary Completion: July 1, 2008
• Study Completion: September 1, 2008
• Last Updated: May 1, 2018
• Results First Posted: June 6, 2013

Record last verified: 2018-04

Locations

US (15)