A Multicenter, Open-Label, Non-Comparative Study of the Safety and Contraceptive Efficacy of the Woman's Condom

NCT01223313 | Completed Results DMC

• 1 other identifier: CCN008
• Study Type: interventional
• Target: 511
• Locations: 1 country
• Sites: 10

Brief Summary

WHAT IS THE FEMALE CONDOM? The female condom being examined in this study is investigational (experimental) and is not yet approved by the Food and Drug Administration (FDA). The female condom is made up of a pouch that adjusts to the shape of the vagina. The female condom that will be used in this study is not lubricated, but a water-based lubricant will be provided for you to use with it. Also, the female condoms used in this study will be provided to you at no cost. WHY IS THIS STUDY BEING DONE? The purpose of this study is to find out:

• How well the female condom works to prevent pregnancy
• How well the female condom works to prevent transmission of sexually transmitted diseases
• How safe the female condom is to use
• If urinary tract infections and symptomatic vaginal infections occur while using the female condom
• How well women like the female condom
• How well the female condom performs. WHAT DOES THE STUDY INVOLVE? There will be approximately 10 clinics in the study with about 500 women from all over the United States participating in this study. You are being asked to participate in a research study because you are a woman between the ages of 18 and 40, are in general good health, have regular menstrual cycles, do not want to become pregnant for at least the next 7 months, and are willing to rely on the female condom as your primary method of contraception during study participation. HOW LONG DOES THE STUDY LAST? Enrollment for this study is expected to last about 12 months. You will need to come to the clinic for a screening/admission visit and then 2 or more visits. You will also be asked to complete a diary every day about your use of the female condoms. The clinical staff will help set up your planned clinical visits during the study.

Conditions

Contraception

Keywords

Contraception; Woman's Condom; Female Condom; Condom

Outcome Measures

Primary Outcomes (2)

• 6 Month Pregnancy Probabilities With Typical Use

  Kaplan-Meier methods will be used to estimate the six-month cumulative pregnancy probability of women in the MITT population. Pregnancies are not included if they are found to have occurred before a subject was enrolled or after she has discontinued using the study product as her primary method of contraception. The pregnancy probability is reported as a percentage.

  Assessed at 1 Month, 3 Months, and 6 Months, up to 6 Months

• 6 Month Pearl Rate With Typical Use

  Pearl rate will be calculated based on the number of woman-months that the subject was at risk for pregnancy. Woman-months of pregnancy risk is defined as the (last date study product considered primary means of contraception - date of enrollment + 1) / 30.4 for women who are not pregnant and as (date of conception - date of enrollment + 1) / 30.4 for women who became pregnant during the study.

  6 Months

Secondary Outcomes (13)

• 6 Month Pregnancy Probabilities With Perfect Use

  Assessed at 1 Month, 3 Months, and 6 Months, up to 6 Months

• Incidence of Chlamydia During the Study

  Visit 1 (Screening) and Visit 3 (Exit), up to 6 months

• Incidence of Gonorrhea During the Study

  Visit 1 (Screening) and Visit 3 (Exit), up to 6 months

• Change From Baseline in Urinary Tract Infections (UTIs)

  Visit 1/Screening and Visit 3/Exit, up to 6 months

• Change From Baseline in Bacterial Vaginosis (BV)

  Visit 1/Screening and Visit 3/Exit, up to 6 months

Study Arms (1)

Woman's Condom

EXPERIMENTAL

The Woman's Condom (WC) is an investigational device manufactured by Shanghai Dahua Medical Apparatus Corp., Ltd (Dahua). Dahua's quality management system complies with ISO9001:2000, ISO13485:2003, MDD93/42/EEC. The WC consists of a 0.03-mm-thick pliable plastic pouch that easily conforms to the shape of the vagina. It is 22.9 cm (± 0.3 cm)(9 inches ± 0.1 inch) long and has a flexible soft outer ring that is designed to hug the external genitalia. The foam shapes on the outside of the pouch cling lightly to vaginal walls, ensuring stability of the device. The insertion capsule is made from dissolvable polyvinyl alcohol (PVA) and is similar to the PVA used in C-Film (Apothecus Pharmaceutical Corporation, New York, NY). The WC is a non-lubricated device. It is supplied with water-soluble lubricant with a chemical composition similar to a commercially available lubricant used in previous studies of the WC. Women will receive instruction sheets on the use of the WC and lubricant.

Device: Woman's Condom

Interventions

Woman's Condom DEVICE

The Woman's Condom (WC) is an investigational device manufactured by Shanghai Dahua Medical Apparatus Corp., Ltd (Dahua). Dahua's quality management system complies with ISO9001:2000, ISO13485:2003, MDD93/42/EEC. The WC consists of a 0.03-mm-thick pliable plastic pouch that easily conforms to the shape of the vagina. It is 22.9 cm (± 0.3 cm)(9 inches ± 0.1 inch) long and has a flexible soft outer ring that is designed to hug the external genitalia. The foam shapes on the outside of the pouch cling lightly to vaginal walls, ensuring stability of the device. The insertion capsule is made from dissolvable polyvinyl alcohol (PVA) and is similar to the PVA used in C-Film (Apothecus Pharmaceutical Corporation, New York, NY). The WC is a non-lubricated device. It is supplied with water-soluble lubricant with a chemical composition similar to a commercially available lubricant used in previous studies of the WC. Women will receive instruction sheets on the use of the WC and lubricant.

Woman's Condom

Eligibility Criteria

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

You may qualify if:

• To enroll into the clinical trial, 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 at enrollment.
• Have a negative urine pregnancy test at the admission visit.
• Have a history of regular cyclic menses with a usual length of 21 to 35 days when not using hormonal contraception.
• Have one menses after switching from oral contraceptives to using the Woman's Condom.
• Have at least one spontaneous menstrual cycle (two menses) following a pregnancy that ended at 14 or more weeks gestation.
• Have at least one cycle (two menses) after an abortion at less than 14 weeks gestation.
• Be willing to accept a risk of pregnancy.
• Be willing to engage in at least four acts of heterosexual vaginal intercourse per month for a period of 6 months.
• Be willing to only use the study product as the primary method of contraception over the course of the study.
• 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 any symptoms, which occurred in her or her partner over the course of study participation.
• Be willing to state that, to her best knowledge, her sexual partner(s):
• Has not had a vasectomy or been previously diagnosed as infertile.

You may not qualify if:

• To enroll into the clinical trial, potential subjects must not:
• Have a history of allergy or sensitivity to polyurethane (condom pouch), polyvinyl alcohol (capsule), or other water-based lubricants such as Astroglide.
• Have current UTI or symptomatic vaginal infection as confirmed by dipstick urinalysis, or if needed by a urine culture or wet mount (see Schedule of Assessments for definitions), unless treated and proof of cure is documented by a negative test result performed at least 2 weeks post-treatment.
• Have evidence of Chlamydia trachomatis or Neisseria gonorrhea infection unless she and her partner(s) complete treatment and proof of cure is documented for the subject only by a negative test result performed at least 3 weeks post-treatment.
• Be pregnant, have a suspected pregnancy or desire to become pregnant during the course of the study.
• Have a history of infertility or pelvic inflammatory disease without a subsequent spontaneous intrauterine pregnancy.
• Have been diagnosed with pelvic inflammatory disease (PID) without a subsequent intrauterine pregnancy.
• Be in a monogamous relationship of less than 4 months with their partner.
• Have shared injection drug needles in the past unless has a negative HIV test at least 6 weeks since last use.
• Have known or suspected to have an HIV infection.
• Have been diagnosed with genital herpes simplex virus (HSV), with the first occurrence (initial episode) within 3 months prior to screening or have clinical evidence of HSV on exam.
• Be lactating or breastfeeding.
• Have any clinically significant abnormal vaginal bleeding or spotting within the month prior to screening.
• Have had vaginal or cervical biopsy or vaginal surgery within 3 months prior to screening.
• Have used vaginal or systemic antibiotics or antifungal agents within 14 days prior to screening or enrollment.

Sponsors & Collaborators

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

Study Sites (10)

California Family Health Council, Inc

Los Angeles, California, 90010, United States

Location

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

NYU Medical Center Family Planning

New York, New York, 10016, United States

Location

Columbia University

New York, New York, 10032, United States

Location

University of Cininnati College of Medicine

Cincinnati, Ohio, 45267, United States

Location

Oregon Health Scieces University

Portland, Oregon, 97239, United States

Location

University of Pennsylvania Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

UT Southwestern Medical Center Dept. of OB/Gyn

Dallas, Texas, 75390, United States

Location

Jones Institute of Reproductive Medicine

Norfolk, Virginia, 23507, United States

Location

Related Publications (2)

• Walsh TL, Snead MC, St Claire BJ, Schwartz JL, Mauck CK, Frezieres RG, Blithe DL, Archer DF, Barnhart KT, Jensen JT, Nelson AL, Thomas MA, Wan LS, Weaver MA. Comparison of self-reported female condom failure and biomarker-confirmed semen exposure. Contraception. 2019 Nov;100(5):406-412. doi: 10.1016/j.contraception.2019.07.143. Epub 2019 Aug 2.

  PMID: 31381878 DERIVED

• Chen BA, Blithe DL, Muraguri GR, Lance AA, Carr BR, Jensen JT, Kimble TD, Murthy AS, Schreiber CA, Thomas MA, Walsh TL, Westhoff C, Burke AE. Acceptability of the Woman's Condom in a phase III multicenter open-label study. Contraception. 2019 Jun;99(6):357-362. doi: 10.1016/j.contraception.2019.02.006. Epub 2019 Mar 6.

  PMID: 30849305 DERIVED

Results Point of Contact

• Title: Dr. Jill Long
• Organization: NICHD Medical Officer

jill.long@nih.gov

301-496-1662

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2010
• First Posted: October 18, 2010
• Study Start: January 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: September 1, 2015
• Last Updated: February 9, 2026
• Results First Posted: February 9, 2026

Record last verified: 2026-01

Locations

US (10)