ContraceptionNCT01223313

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

A study testing Woman's Condom in people with Contraception, run by Premier Research at 10 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for: Contraception
What is being tested?: Woman's Condom
Type of treatment: Pill or oral medicine, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 511 participants
Where: 10 sitesUnited States
Study dates: Jan 2011to Sep 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 40 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

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.

Show all 21Show fewer

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.
Has not been previously diagnosed or suspected of HIV unless he has subsequently had a negative HIV test.
Has not been known to have engaged in homosexual intercourse in the past 5 years unless he has had negative HIV test results since then.
Has not shared injection drug needles in the past unless he has had a negative HIV test at least 6 weeks since last use.
Has no known history of allergy or sensitivity to polyurethane (condom pouch), polyvinyl alcohol (capsule), or other water-based lubricants such as Astroglide.
Agree not to participate in any other clinical trials during the course of this study.
Be willing to give written informed consent to participate in the trial.

Who cannot join

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.

Show all 32Show fewer

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 any contraindications to pregnancy (medical condition) or regularly use category D or X or exclusionary medications listed in Appendix F.
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.
Have received a Depo-Provera® injection in the 9 months prior to enrollment (this exclusionary time period can be shortened to 6 months if the subject has also had 2 spontaneous menstrual cycles [requires minimum of 3 menses] that meet criteria for normal menstrual cycles).
Have an abnormal Pap test based on the following criteria:
Pap test in the past 15 months with ASC-US unless:
less than 21 years of age;
a repeat Pap test at least 6 months later was normal;
reflex HPV testing was performed and was negative for high-risk HPV; or
a colposcopy (with or without biopsy) found no evidence of dysplasia requiring treatment or treatment was performed and follow-up at least 6 months after the treatment showed no evidence of disease;
Pap test in the past 15 months with LSIL unless:
less than 21 years of age;
a colposcopy (with or without biopsy) found no evidence of dysplasia requiring treatment or treatment was performed and follow-up at least 6 months after the treatment showed no evidence of disease;
Pap test in the past 15 months with ASC-H, atypical glandular cells, or HSIL unless colposcopy and/or treatment was performed and follow-up at least 6 months after the colposcopy and/or treatment showed no evidence of disease;
Pap test in the past 15 months with malignant cells.
Have a past (within 12 months) or current history of alcohol or drug [recreational, prescription or over-the-counter (OTC)] abuse.
Have taken an investigational drug or used an investigational device within the past 30 days.
Have previously participated in or completed this study.
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. For example, if the subject is found to have Condyloma Accuminata, the investigator can decide whether to exclude the subject or not, depending on its location and if use of the condom may be painful for the subject.

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

United States10 sites

Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
University of Cininnati College of Medicine
Cincinnati, Ohio, 45267
UT Southwestern Medical Center Dept. of OB/Gyn
Dallas, Texas, 75390
California Family Health Council, Inc
Los Angeles, California, 90010
NYU Medical Center Family Planning
New York, New York, 10016
Columbia University
New York, New York, 10032
Jones Institute of Reproductive Medicine
Norfolk, Virginia, 23507
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, 19104
Magee-Womens Hospital
Pittsburgh, Pennsylvania, 15213
Oregon Health Scieces University
Portland, Oregon, 97239

Other trials in United States

About this study

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.

Read the detailed description

This is a Phase III multicenter, open-label, non-comparative trial of the Woman's Condom to evaluate contraceptive efficacy as the primary method of contraception. Secondary evaluations include safety assessment, incidence of UTIs, symptomatic vaginal infection, performance of the Woman's Condom (clinical breakage, slippage, misdirection, and invagination) and overall acceptability of the product. We will perform a Substudy to assess the semen biomarker as a means of detecting product failure in a subset of subjects.

Conditions: Contraception
Being tested: Woman's Condom
Keywords: Contraception, Woman's Condom, Female Condom, Condom

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Woman's CondomDevice
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.

Study groups in NCT01223313
Study group	Role	What they receive
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. Receives: Device: Woman's Condom

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 6 Months

Secondary outcomes (13)

6 Month Pregnancy Probabilities With Perfect Use
Kaplan-Meier methods will be used to estimate the six-month cumulative pregnancy probability of women in the Efficacy Evaluable population. Each woman in the Efficacy Evaluable population contributes efficacy for menstrual cycles where she has used the assigned product consistently and correctly as reflected in her diary recordings. Pregnancies that 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 are not included. The pregnancy probability is reported as a percentage.
Measured: Assessed at 1 Month, 3 Months, and 6 Months, up to 6 Months
Incidence of Chlamydia During the Study
Incidence of acquisition of Chlamydia evaluated at screening and end of the study.
Measured: Visit 1 (Screening) and Visit 3 (Exit), up to 6 months
Incidence of Gonorrhea During the Study
Incidence of acquisition of Gonorrhea evaluated at screening and end of the study.
Measured: Visit 1 (Screening) and Visit 3 (Exit), up to 6 months
Change From Baseline in Urinary Tract Infections (UTIs)
Change from Baseline of urinary tract infections (UTIs)
Measured: Visit 1/Screening and Visit 3/Exit, up to 6 months
Change From Baseline in Bacterial Vaginosis (BV)
Change from Baseline of bacterial vaginosis (BV)
Measured: Visit 1/Screening and Visit 3/Exit, up to 6 months
Change From Baseline in Monilia
Change from Baseline of Monilia
Measured: Visit 1/Screening and Visit 3/Exit, up to 6 months
Incidence of Trichomoniasis During the Study
Incidence of acquisition of Trichomoniasis evaluated at screening and end of the study.
Measured: Visit 1 (Screening) and Visit 3 (Exit), up to 6 months
Number of Women That Preferred Female Condom Over Male Condom After Cycle 6
Acceptability of the Woman's Condom as measured by an acceptability questionnaire administered at study exit (visit 3, after menstrual cycle 6 or early discontinuation).
Measured: Visit 3 (Cycle 6), up to 6 months
Percentage of Uses With Clinical Breakage With the Woman's Condom
Performance of the Woman's Condom as assessed by self-reported clinical breakage based on percent of uses. Breakage of the female condom during intercourse or during withdrawal of the condom from the vagina. Clinical breakage is breakage with potential adverse health consequences and includes events in which the outer frame or ring breaks. It is calculated by dividing the number of female condoms reported to have broken during intercourse or withdrawal by the number of female condoms used during intercourse.
Measured: Up to 6 months of use
Percentage of Uses With Misdirection With the Woman's Condom
Performance of the Woman's Condom as assessed by self-reported misdirection based on percent of uses. Vaginal penetration whereby the penis is inserted between the female condom and the vaginal wall and is calculated by dividing the number of reported incidences of misdirection by the number of female condoms used during intercourse.
Measured: Up to 6 months of use
Percentage of Uses With Slippage With the Woman's Condom
Performance of the Woman's Condom as assessed by self-reported slippage based on percent of uses. A female condom that slips completely out of the vagina during intercourse and is calculated by dividing the number of female condoms that slipped during intercourse by the number of female condoms used during intercourse.
Measured: Up to 6 months of use
Percentage of Uses With Invagination With the Woman's Condom
Performance of the Woman's Condom as assessed by self-reported invagination based on percent of uses. As part of the entire external component of the female condom being pushed into the vagina during intercourse and is calculated by dividing the number of reported incidences of invagination during intercourse by the number of female condoms used during intercourse.
Measured: Up to 6 months of use
Percentage of Uses With Total Clinical Failure With the Woman's Condom
Performance of the Woman's Condom as assessed by total clinical failure based on percent of uses. Total Clinical Failure is defined as the number of female condoms that clinically break, slip, or are associated with reported incidences of misdirection or invagination during intercourse (i.e., any event that might lead to semen spillage) and is calculated by dividing the sum of these events by the number of female condoms used during intercourse.
Measured: Up to 6 months of use

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2011Sep 2015

First posted18 Oct 2010 (estimated)
Study startJan 2011
Primary completionNov 2012
Study completionSep 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for ContraceptionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 511 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01223313
Sponsor's protocol ID: CCN008
Status last verified: Jan 2026
First submitted: 14 Oct 2010
Last updated: 9 Feb 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 31381878
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.
PubMed 30849305

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Open-Label, Non-Comparative Study of the Safety and Contraceptive Efficacy of the Woman's Condom
ClinicalTrials.gov ID: NCT01223313
Acronym / sponsor ID: CCN008
Conditions: Contraception
Keywords: Contraception, Woman's Condom, Female Condom, Condom
Study type: Interventional
Recruitment status: Completed
Enrolment: 511 participants (actual)
Lead sponsor: Premier ResearchUniversity, hospital or other
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study start: Jan 2011
Primary completion: Nov 2012 (actual)
Study completion: Sep 2015 (actual)
First posted: 18 Oct 2010 (estimated)
Results: Posted 9 Feb 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Woman's Condom	Experimental	Device: Woman's CondomThe 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.

Who may qualify

Ages: 18 to 40 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (21 listed)

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.

Key exclusion criteria (32 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Woman's CondomThe 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

Primary outcome

6 Month Pregnancy Probabilities With Typical Use
Time frame: Assessed at 1 Month, 3 Months, and 6 Months, up to 6 Months
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.
6 Month Pearl Rate With Typical Use
Time frame: 6 Months
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.

13 secondary outcomes

6 Month Pregnancy Probabilities With Perfect Use
Time frame: Assessed at 1 Month, 3 Months, and 6 Months, up to 6 Months
Incidence of Chlamydia During the Study
Time frame: Visit 1 (Screening) and Visit 3 (Exit), up to 6 months
Incidence of Gonorrhea During the Study
Time frame: Visit 1 (Screening) and Visit 3 (Exit), up to 6 months
Change From Baseline in Urinary Tract Infections (UTIs)
Time frame: Visit 1/Screening and Visit 3/Exit, up to 6 months
Change From Baseline in Bacterial Vaginosis (BV)
Time frame: Visit 1/Screening and Visit 3/Exit, up to 6 months
Change From Baseline in Monilia
Time frame: Visit 1/Screening and Visit 3/Exit, up to 6 months
Incidence of Trichomoniasis During the Study
Time frame: Visit 1 (Screening) and Visit 3 (Exit), up to 6 months
Number of Women That Preferred Female Condom Over Male Condom After Cycle 6
Time frame: Visit 3 (Cycle 6), up to 6 months
Percentage of Uses With Clinical Breakage With the Woman's Condom
Time frame: Up to 6 months of use
Percentage of Uses With Misdirection With the Woman's Condom
Time frame: Up to 6 months of use
Percentage of Uses With Slippage With the Woman's Condom
Time frame: Up to 6 months of use
Percentage of Uses With Invagination With the Woman's Condom
Time frame: Up to 6 months of use
Percentage of Uses With Total Clinical Failure With the Woman's Condom
Time frame: Up to 6 months of use

Results and safety

Results posted to the registry on 9 Feb 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Woman's Condom	511	278

Primary outcome: 6 Month Pregnancy Probabilities With Typical Use

Time frame: Assessed at 1 Month, 3 Months, and 6 Months, up to 6 Months. Number (95% Confidence Interval). Unit: percentage of probability

Measure	Woman's Condom n = 401
1 Month Pregnancy Probability	0.5 (0.0 to 1.2)
3 Month Pregnancy Probability	1.4 (0.1 to 2.6)
6 Month Pregnancy Probability	4.0 (1.6 to 6.3)

Population analysed: enrolled subjects whose diaries indicated they had at least one episode of coitus while using the assigned study product and for whom there is at least one report of pregnancy status.

Primary outcome: 6 Month Pearl Rate With Typical Use

Time frame: 6 Months. Number. Unit: Pregnancies per 100 women-years

Measure	Woman's Condom n = 405
Value	8.03

13 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months, immediately after informed consent has been obtained and lasts through the study Exit Visit, up to 6 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Woman's Condom	1 of 405 (0.2%)	102 of 405 (25.2%)	0 of 405

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31381878Walsh 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.
Derived from this study: PubMed 30849305Chen 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Woman's Condom in people with Contraception, run by Premier Research at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

6 Month Pregnancy Probabilities With Typical Use (time frame: Assessed at 1 Month, 3 Months, and 6 Months, up to 6 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01223313, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.