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

A Phase II/III Multicenter, Randomized, Double-masked, Study of the Safety and Contraceptive Efficacy of C31G Compared to Conceptrol®

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy
• Intervention / Treatment: Drug: C31G; Drug: nonoxynol-9 (N-9)

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.

• Study Type: Interventional
• Enrollment (Actual): 1565
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Berkeley, California, United States, 94710
      • California Family Health Council
    • Los Angeles, California, United States, 90010
      • California Family Health Council
  • Colorado
    • Aurora, Colorado, United States, 80010
      • University of Colorado - Advanced reproductive Medicine
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Johns Hopkins Bayview Medical Center
  • Massachusetts
    • Springfield, Massachusetts, United States, 01199
      • Bay State Medical Center
  • New York
    • New York, New York, United States, 10032
      • Columbia University
    • New York, New York, United States, 10016
      • New York University
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • University of Cincinnati
    • Cleveland, Ohio, United States, 44106
      • University Hospitals of Cleveland MacDonald Women's Hospital
    • Columbus, Ohio, United States, 43210
      • The Ohio State University College of Medicine
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania Medical Center
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh
  • Texas
    • Dallas, Texas, United States, 75390
      • U.T. Southwestern Medical Center
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Jones Institute of Reproductive Medicine, EVMS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Adverse Events.	Evaluated by comparing the incidence of Adverse Events (AEs) among subjects using their assigned treatment for at least one day.	duration of the study - through 6 month or 12 months of use

Collaborators and Investigators

• Sponsor: Health Decisions
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Study Director: Diana L Blithe, Ph.D., Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2004
• Primary Completion (ACTUAL): July 1, 2008
• Study Completion (ACTUAL): September 1, 2008

Study Registration Dates

• First Submitted: January 6, 2006
• First Submitted That Met QC Criteria: January 6, 2006
• First Posted (ESTIMATE): January 10, 2006

Study Record Updates

• Last Update Posted (ACTUAL): May 1, 2018
• Last Update Submitted That Met QC Criteria: April 27, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: contraception
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Contraceptive Agents; Reproductive Control Agents; Contraceptive Agents, Female; Contraceptive Agents, Male; Spermatocidal Agents; Antispermatogenic Agents; Nonoxynol
• Other Study ID Numbers: CCN004; HHSN2752004033661