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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00274261
First received: January 6, 2006
Last updated: April 30, 2013
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Pregnancy
Drug: C31G
Drug: nonoxynol-9 (N-9)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: A Phase II/III Multicenter, Randomized, Double-masked, Study of the Safety and Contraceptive Efficacy of C31G Compared to Conceptrol®

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • The Cumulative Probability of Typical-use 6 Month (183 Days) Pregnancy. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Incidence of Adverse Events. [ Time Frame: The DSMB will review safety data at 3 months following 200 subjects enrolled, 3 months following 400 subject enrolled, as well as additional meetings as needed. ] [ Designated as safety issue: Yes ]
    Evaluated by comparing the incidence of Adverse Events (AEs) among subjects using their assigned treatment for at least one day.


Enrollment: 1565
Study Start Date: June 2004
Study Completion Date: September 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
C31G vaginal gel contains 35mg (1% concentration) of C31G in 3.5 mL volume of gel
Drug: C31G
The subject will insert one applicator of C31G prior to each episode of vaginal intercourse during her participation in the study.
Active Comparator: B
Conceptrol® Vaginal gel contains 100mg (4% concentration) of nonoxynol-9 (N-9) in 2.5 mL volume of gel.
Drug: nonoxynol-9 (N-9)
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.

Detailed Description:

Approximately 85% of American women (52 million) between the ages of 15 and 44 are sexually active . Approximately two-thirds or 38 million women use some form of birth control and/or STD prevention. With growing awareness of the risk of STDs, increasing numbers of women will require contraceptive methods that provide protection against STDs in addition to providing the basic contraceptive function. Currently there is no single, reasonably effective method to achieve both ends. Condoms, both male and female, present problems of acceptability for the partners of many at-risk women and, thus, cannot be considered an effective contraceptive and STD preventive for many people. A spermicide that also has the ability to prevent transmission of STDs would be a major advance, and of tremendous value to women worldwide.

C31G is an effective spermicide with in vitro activity equal to that of N-9 . C31G has been found to be a broad-spectrum antibacterial agent in vitro or in animals, active against both gram-positive and gram-negative organisms, including chlamydia, and a range of antibiotic resistant strains. It is also active against enveloped viruses including HIV and HSV. Thus, the primary objective of the study is to determine the contraceptive efficacy of C31G vaginal gel compared to Conceptrol® Vaginal Gel. The secondary objectives are to determine the safety and acceptability of the compounds with use over a period of six months or twelve months. Additional evaluations include the incidence of urinary tract infections (UTI), bacterial vaginosis (BV) and yeast vaginitis following the use of C31G vaginal gel compared to Conceptrol® Vaginal Gel.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.
  • Have a past history (within twelve months) or current history of drug abuse [recreational, prescription or over-the-counter (OTC)].
  • Have taken an investigational drug or used an investigational device within the past 30 days.
  • Have previously participated in or completed this study or any other phase III study of C31G.
  • Have issues or concerns (in the judgment of the investigator) that may compromise the safety of the subject or confound the reliability of compliance and information acquired in this study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00274261

Locations
United States, California
California Family Health Council
Berkeley, California, United States, 94710
California Family Health Council
Los Angeles, California, United States, 90010
United States, Colorado
University of Colorado - Advanced reproductive Medicine
Aurora, Colorado, United States, 80010
United States, Maryland
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
United States, Massachusetts
Bay State Medical Center
Springfield, Massachusetts, United States, 01199
United States, New York
New York University
New York, New York, United States, 10016
Columbia University
New York, New York, United States, 10032
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267
University Hospitals of Cleveland MacDonald Women's Hospital
Cleveland, Ohio, United States, 44106
The Ohio State University College of Medicine
Columbus, Ohio, United States, 43210
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, United States, 19104
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
U.T. Southwestern Medical Center
Dallas, Texas, United States, 75390
United States, Virginia
Jones Institute of Reproductive Medicine, EVMS
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
Investigators
Study Director: Diana L Blithe, Ph.D. Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  More Information

No publications provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT00274261     History of Changes
Other Study ID Numbers: HHSN27500002, HHSN2752004033661
Study First Received: January 6, 2006
Results First Received: December 14, 2012
Last Updated: April 30, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
contraception

Additional relevant MeSH terms:
Contraceptive Agents
Nonoxynol
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Spermatocidal Agents
Antispermatogenic Agents
Contraceptive Agents, Female
Contraceptive Agents, Male

ClinicalTrials.gov processed this record on April 23, 2014