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

Completed · Phase 3

Conditions studied: Pregnancy

In brief

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.

Key facts

Study ID: NCT00274261
Run by: Premier Research
People needed: 1565
Starts: 2004-06-01
Expected to finish: 2008-09-01
Last updated by the study team: 2018-05-01

Who can join

Age: 18 and older, up to 40. Sex: female. Healthy volunteers: accepted.

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.
Have any clinically significant abnormal finding on pelvic examination or baseline labs, which in the view of the investigator, precludes her from participating in the trial.
Have clinically significant signs of vaginal or cervical irritation on pelvic examination.
Have had vaginal or cervical biopsy or vaginal surgery within 3 months prior to screening.
Have used vaginal or systemic antibiotics or antifungals within 14 days prior to screening or randomization.
Have had a Depo-Provera® injection in the 10 months prior to enrollment.
Have an abnormal Pap smear with high grade squamous intraepithelial lesion (HSIL), atypical glandular cells (AGC) or ASC-H (atypical squamous cells, cannot exclude HSIL) within the last 12 months.
Have an abnormal Pap smear with low-grade squamous intraepithelial lesion (LSIL) or ASCUS-HPV HR positive unless resolved by colposcopy.
Have a Cervical Intraepithelial Neoplasia (CIN) diagnosis by biopsy within the last 12 months.
Have a history or a current diagnosis of cervical cancer.
Consume (on average) greater than three drinks of an alcoholic beverage per day.

Where it is running

California Family Health Council — Berkeley, California, United States
California Family Health Council — Los Angeles, California, United States
University of Colorado - Advanced reproductive Medicine — Aurora, Colorado, United States
Johns Hopkins Bayview Medical Center — Baltimore, Maryland, United States
Bay State Medical Center — Springfield, Massachusetts, United States
New York University — New York, New York, United States
Columbia University — New York, New York, United States
University of Cincinnati — Cincinnati, Ohio, United States
University Hospitals of Cleveland MacDonald Women's Hospital — Cleveland, Ohio, United States
The Ohio State University College of Medicine — Columbus, Ohio, United States
Oregon Health & Science University — Portland, Oregon, United States
University of Pennsylvania Medical Center — Philadelphia, Pennsylvania, United States
University of Pittsburgh — Pittsburgh, Pennsylvania, United States
U.T. Southwestern Medical Center — Dallas, Texas, United States
Jones Institute of Reproductive Medicine, EVMS — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.