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CompletedNCT01223313Updated Feb 9, 2026Results posted

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

An interventional study of Woman's Condom in Contraception, sponsored by Premier Research. Completed at 10 sites in United States. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-09.

Sponsored by Premier Research · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
511
Allocation
Not applicable
Ages
18 Years to 40 Years
Sex
Female
01

Study 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.

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.

02

Conditions studied

  • Contraception

Keywords

  • Contraception
  • Woman's Condom
  • Female Condom
  • Condom
03

In context

Lead sponsor

Premier Research is the lead sponsor of 9 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

To enroll into the clinical trial, potential subjects must:

  1. Be healthy women, who are sexually active, at risk for pregnancy and desiring .
  2. Be within the age range of 18 through 40 years inclusive at enrollment.
  3. Have a negative urine pregnancy test at the admission visit.
  4. Have a history of regular cyclic menses with a usual length of 21 to 35 days when not using hormonal contraception.
  5. Have one menses after switching from oral contraceptives to using the Woman's Condom.
  6. Have at least one spontaneous menstrual cycle (two menses) following a pregnancy that ended at 14 or more weeks gestation.
  7. Have at least one cycle (two menses) after an abortion at less than 14 weeks gestation.
  8. Be willing to accept a risk of pregnancy.
  9. Be willing to engage in at least four acts of heterosexual vaginal intercourse per month for a period of 6 months.
  10. Be willing to only use the study product as the primary method of contraception over the course of the study.
  11. Be capable of using the study product properly and agree to observe all study directions and requirements.
  12. 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.

  13. Be willing to state that, to her best knowledge, her sexual partner(s):

    1. Has not had a vasectomy or been previously diagnosed as infertile.
    2. Has not been previously diagnosed or suspected of unless he has subsequently had a negative HIV test.
    3. 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.
    4. Has not shared injection drug needles in the past unless he has had a negative HIV test at least 6 weeks since last use.
    5. Has no known history of allergy or sensitivity to polyurethane (condom pouch), polyvinyl alcohol (capsule), or other water-based lubricants such as Astroglide.
  14. Agree not to participate in any other clinical trials during the course of this study.
  15. Be willing to give written to participate in the trial.

Exclusion criteria

Exclusion Criteria

To enroll into the clinical trial, potential subjects must not:

  1. Have a history of allergy or sensitivity to polyurethane (condom pouch), polyvinyl alcohol (capsule), or other water-based lubricants such as Astroglide.
  2. 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.
  3. 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.
  4. Be pregnant, have a suspected pregnancy or desire to become pregnant during the course of the study.
  5. Have a history of infertility or pelvic inflammatory disease without a subsequent spontaneous intrauterine pregnancy.
  6. Have been diagnosed with pelvic inflammatory disease (PID) without a subsequent intrauterine pregnancy.
  7. Be in a monogamous relationship of less than 4 months with their partner.
  8. Have any to pregnancy (medical condition) or regularly use category D or X or exclusionary medications listed in Appendix F.
  9. Have shared injection drug needles in the past unless has a negative test at least 6 weeks since last use.
  10. Have known or suspected to have an HIV infection.
  11. 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.
  12. Be lactating or breastfeeding.
  13. Have any abnormal vaginal bleeding or spotting within the month prior to screening.
  14. Have had vaginal or cervical or vaginal surgery within 3 months prior to screening.
  15. Have used vaginal or systemic antibiotics or antifungal agents within 14 days prior to screening or enrollment.
  16. 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).

  17. 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.
  18. Have a past (within 12 months) or current history of alcohol or drug [recreational, prescription or over-the-counter (OTC)] abuse.
  19. Have taken an drug or used an investigational device within the past 30 days.
  20. Have previously participated in or completed this study.
  21. 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.
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
511 participants (actual)

Study arms

  • Experimental
    Woman's Condom

    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

  • DeviceWoman's Condom

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Assessed at 1 Month, 3 Months, and 6 Months, up to 6 Months

  2. 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.

    Time frame: 6 Months

Secondary outcomes

  1. 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.

    Time frame: Assessed at 1 Month, 3 Months, and 6 Months, up to 6 Months

  2. Incidence of Chlamydia During the Study

    Incidence of acquisition of Chlamydia evaluated at screening and end of the study.

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

  3. Incidence of Gonorrhea During the Study

    Incidence of acquisition of Gonorrhea evaluated at screening and end of the study.

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

  4. Change From Baseline in Urinary Tract Infections (UTIs)

    Change from Baseline of urinary tract infections (UTIs)

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

  5. Change From Baseline in Bacterial Vaginosis (BV)

    Change from Baseline of bacterial vaginosis (BV)

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

  6. Change From Baseline in Monilia

    Change from Baseline of Monilia

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

  7. Incidence of Trichomoniasis During the Study

    Incidence of acquisition of Trichomoniasis evaluated at screening and end of the study.

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

  8. 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).

    Time frame: Visit 3 (Cycle 6), up to 6 months

  9. 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.

    Time frame: Up to 6 months of use

  10. 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.

    Time frame: Up to 6 months of use

  11. 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.

    Time frame: Up to 6 months of use

  12. 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.

    Time frame: Up to 6 months of use

  13. 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.

    Time frame: Up to 6 months of use

07

Results

Posted Feb 9, 2026

Participant flow

Participant flow — Overall Study
MilestoneWoman's Condom
Started511
Completed278
Not completed233

Outcome measures

Primary6 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.

Time frame:
Assessed at 1 Month, 3 Months, and 6 Months, up to 6 Months
Reported as:
Number · percentage of probability
6 Month Pregnancy Probabilities With Typical Use
percentage of probabilityWoman's Condom
1 Month Pregnancy Probability0.5 (0.0 to 1.2)
3 Month Pregnancy Probability1.4 (0.1 to 2.6)
6 Month Pregnancy Probability4.0 (1.6 to 6.3)
Secondary6 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.

Time frame:
Assessed at 1 Month, 3 Months, and 6 Months, up to 6 Months
Reported as:
Number · percentage of probability
6 Month Pregnancy Probabilities With Perfect Use
percentage of probabilityWoman's Condom
1 Month Pregnancy Probability0.0 (0.0 to 0.0)
3 Month Pregnancy Probability0.4 (0.0 to 1.1)
6 Month Pregnancy Probability2.6 (0.4 to 4.7)
SecondaryIncidence of Chlamydia During the Study

Incidence of acquisition of Chlamydia evaluated at screening and end of the study.

Time frame:
Visit 1 (Screening) and Visit 3 (Exit), up to 6 months
Reported as:
Count of participants · Participants
Incidence of Chlamydia During the Study
ParticipantsWoman's Condom
Positive Chlamydia at Visit 1/Screening7
Positive Chlamydia at Visit 3/Exit4
SecondaryIncidence of Gonorrhea During the Study

Incidence of acquisition of Gonorrhea evaluated at screening and end of the study.

Time frame:
Visit 1 (Screening) and Visit 3 (Exit), up to 6 months
Reported as:
Count of participants · Participants
Incidence of Gonorrhea During the Study
ParticipantsWoman's Condom
Positive Gonorrhea at Visit 1/Screening4
Positive Gonorrhea at Visit 3/Exit6
SecondaryChange From Baseline in Urinary Tract Infections (UTIs)

Change from Baseline of urinary tract infections (UTIs)

Time frame:
Visit 1/Screening and Visit 3/Exit, up to 6 months
Reported as:
Count of participants · Participants
Change From Baseline in Urinary Tract Infections (UTIs)
ParticipantsWoman's Condom
Subjects with No Change from Baseline373
Subjects Improved from Baseline2
Subjects Worsened from Baseline3
SecondaryChange From Baseline in Bacterial Vaginosis (BV)

Change from Baseline of bacterial vaginosis (BV)

Time frame:
Visit 1/Screening and Visit 3/Exit, up to 6 months
Reported as:
Count of participants · Participants
Change From Baseline in Bacterial Vaginosis (BV)
ParticipantsWoman's Condom
Subjects with No Change from Baseline222
Subjects Improved from Baseline3
Subjects Worsened from Baseline9
SecondaryChange From Baseline in Monilia

Change from Baseline of Monilia

Time frame:
Visit 1/Screening and Visit 3/Exit, up to 6 months
Reported as:
Count of participants · Participants
Change From Baseline in Monilia
ParticipantsWoman's Condom
Subjects with No Change from Baseline10
Subjects Improved from Baseline0
Subjects Worsened from Baseline0
Primary6 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.

Time frame:
6 Months
Reported as:
Number · Pregnancies per 100 women-years
6 Month Pearl Rate With Typical Use
Pregnancies per 100 women-yearsWoman's Condom
6 Month Pearl Rate With Typical Use8.03
SecondaryIncidence of Trichomoniasis During the Study

Incidence of acquisition of Trichomoniasis evaluated at screening and end of the study.

Time frame:
Visit 1 (Screening) and Visit 3 (Exit), up to 6 months
Reported as:
Count of participants · Participants
Incidence of Trichomoniasis During the Study
ParticipantsWoman's Condom
Positive Gonorrhea at Visit 1/Screening3
Positive Gonorrhea at Visit 3/Exit0
SecondaryNumber 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).

Time frame:
Visit 3 (Cycle 6), up to 6 months
Reported as:
Count of participants · Participants
Number of Women That Preferred Female Condom Over Male Condom After Cycle 6
ParticipantsWoman's Condom
Number of Women That Preferred Female Condom Over Male Condom After Cycle 681
SecondaryPercentage 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.

Time frame:
Up to 6 months of use
Reported as:
Mean · percentage
Percentage of Uses With Clinical Breakage With the Woman's Condom
percentageWoman's Condom
Percentage of Uses With Clinical Breakage With the Woman's Condom1.2 ± 6.44
SecondaryPercentage 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.

Time frame:
Up to 6 months of use
Reported as:
Mean · percentage
Percentage of Uses With Misdirection With the Woman's Condom
percentageWoman's Condom
Percentage of Uses With Misdirection With the Woman's Condom2.2 ± 7.79
SecondaryPercentage 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.

Time frame:
Up to 6 months of use
Reported as:
Mean · percentage
Percentage of Uses With Slippage With the Woman's Condom
percentageWoman's Condom
Percentage of Uses With Slippage With the Woman's Condom4.3 ± 13.24
SecondaryPercentage 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.

Time frame:
Up to 6 months of use
Reported as:
Mean · percentage
Percentage of Uses With Invagination With the Woman's Condom
percentageWoman's Condom
Percentage of Uses With Invagination With the Woman's Condom1.9 ± 7.48
SecondaryPercentage 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.

Time frame:
Up to 6 months of use
Reported as:
Mean · percentage
Percentage of Uses With Total Clinical Failure With the Woman's Condom
percentageWoman's Condom
Percentage of Uses With Total Clinical Failure With the Woman's Condom8.0 ± 16.31

Adverse events

Collected over 6 months, immediately after informed consent has been obtained and lasts through the study Exit Visit, up to 6 months.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Woman's Condom0/405 (0%)1/405 (0.2%)102/405 (25.2%)
Most frequent serious events
Most frequent serious events
EventWoman's Condom
ConvulsionNervous system disorders1/405
Most frequent other events
Showing 10 of 36
Most frequent other events
EventWoman's Condom
Vaginitis bacterialInfections and infestations19/405
Vulvovaginal discomfortReproductive system and breast disorders19/405
Urinary tract infectionInfections and infestations17/405
Vulvovaginal mycotic infectionInfections and infestations17/405
Vulvovaginal pruritusReproductive system and breast disorders12/405
Vaginal dischargeReproductive system and breast disorders7/405
Vulvovaginal burning sensationReproductive system and breast disorders7/405
Chlamydial infectionInfections and infestations6/405
DysuriaRenal and urinary disorders6/405
MetrorrhagiaReproductive system and breast disorders6/405

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Woman's Condom
<=18 years0
Between 18 and 65 years511
>=65 years0
Age, Continuous
Age, Continuous(years)Woman's Condom
Mean28.4 ± 6.13
Sex: Female, Male
Sex: Female, Male(Participants)Woman's Condom
Female511
Male0
Region of Enrollment
Region of Enrollment(participants)Woman's Condom
United States511
08

Study locations

10 sites
  • California Family Health Council, Inc
    Los Angeles, California 90010, United States
  • Johns Hopkins Bayview Medical Center
    Baltimore, Maryland 21224, United States
  • NYU Medical Center Family Planning
    New York, New York 10016, United States
  • Columbia University
    New York, New York 10032, United States
  • University of Cininnati College of Medicine
    Cincinnati, Ohio 45267, United States
  • Oregon Health Scieces University
    Portland, Oregon 97239, United States
  • University of Pennsylvania Medical Center
    Philadelphia, Pennsylvania 19104, United States
  • Magee-Womens Hospital
    Pittsburgh, Pennsylvania 15213, United States
  • UT Southwestern Medical Center Dept. of OB/Gyn
    Dallas, Texas 75390, United States
  • Jones Institute of Reproductive Medicine
    Norfolk, Virginia 23507, United States
09

References and documents

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 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01223313
Lead sponsor
Premier Research
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Responsible party
Sponsor
First posted
Oct 18, 2010
Start date
Jan 2011
Primary completion
Nov 2012
Completion
Sep 2015
Results posted
Feb 9, 2026
Last update
Feb 9, 2026

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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