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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria
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):
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.
Exclusion Criteria
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 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:
Pap test in the past 15 months with LSIL unless:
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Family Health Council, Inc | Los Angeles | California | 90010 | United States | ||
| Johns Hopkins Bayview Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31381878 | Derived | 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. | |
| 30849305 |
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The study was designed to enroll 500 participants. However, the study enrolled 511 participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | Woman's Condom | The Woman's Condom (WC) is an investigational device manufactured by Shanghai Dahua Medical Apparatus Corp., Ltd (Dahua). 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 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| 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. | 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. | 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) | 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) | Visit 1/Screening and Visit 3/Exit, up to 6 months |
| Change From Baseline in Monilia | Change from Baseline of Monilia | 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. | 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). | 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. | 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. | 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. | 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. | 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. | Up to 6 months of use |
| 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 |
| 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Woman's Condom | The Woman's Condom (WC) is an investigational device manufactured by Shanghai Dahua Medical Apparatus Corp., Ltd (Dahua). 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 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of probability | Assessed at 1 Month, 3 Months, and 6 Months, up to 6 Months |
|
|
| ||||||||||||||||||||||||||||||||||
| Secondary | 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. | enrolled subjects whose diaries indicated they had used the assigned study product correctly for every coital act for at least one menstrual cycle and for whom there is at least one report of pregnancy status. | Posted | Number | 95% Confidence Interval | percentage of probability | Assessed at 1 Month, 3 Months, and 6 Months, up to 6 Months |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Incidence of Chlamydia During the Study | Incidence of acquisition of Chlamydia evaluated at screening and end of the study. | Subjects that used at least one Woman's Condom and had chlamydia test performed at the respective visits | Posted | Count of Participants | Participants | Visit 1 (Screening) and Visit 3 (Exit), up to 6 months |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Incidence of Gonorrhea During the Study | Incidence of acquisition of Gonorrhea evaluated at screening and end of the study. | Subjects that used at least one Woman's Condom and had gonorrhea test performed at the respective visits | Posted | Count of Participants | Participants | Visit 1 (Screening) and Visit 3 (Exit), up to 6 months |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Urinary Tract Infections (UTIs) | Change from Baseline of urinary tract infections (UTIs) | only subjects that had both a baseline and exit visit UTI screening were included in the analysis | Posted | Count of Participants | Participants | Visit 1/Screening and Visit 3/Exit, up to 6 months |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Bacterial Vaginosis (BV) | Change from Baseline of bacterial vaginosis (BV) | only subjects that had both a baseline and exit visit BV screening were included in the analysis | Posted | Count of Participants | Participants | Visit 1/Screening and Visit 3/Exit, up to 6 months |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Monilia | Change from Baseline of Monilia | only subjects that had both a baseline and exit visit monilia screening were included in the analysis | Posted | Count of Participants | Participants | Visit 1/Screening and Visit 3/Exit, up to 6 months |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | 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. | 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. | Posted | Number | Pregnancies per 100 women-years | 6 Months | Months | Months |
| |||||||||||||||||||||||||||||||||||
| Secondary | Incidence of Trichomoniasis During the Study | Incidence of acquisition of Trichomoniasis evaluated at screening and end of the study. | Subjects that used at least one Woman's Condom and had trichomoniasis test performed at the respective visits. Subjects were only tested for trichomoniasis if clinically indicated. Therefore, not all subjects were tested. Only 12 subjects were tested for trichomoniasis based on clinical indication for testing. | Posted | Count of Participants | Participants | Visit 1 (Screening) and Visit 3 (Exit), up to 6 months |
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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). | Subjects that completed the questionnaire at exit visit were analyzed | Posted | Count of Participants | Participants | Visit 3 (Cycle 6), up to 6 months |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Subjects that used the Woman's Condom were analyzed | Posted | Mean | Standard Deviation | percentage | Up to 6 months of use |
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Subjects that used the Woman's Condom were analyzed | Posted | Mean | Standard Deviation | percentage | Up to 6 months of use |
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Subjects that used the Woman's Condom were analyzed | Posted | Mean | Standard Deviation | percentage | Up to 6 months of use |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | 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. | Subjects that used the Woman's Condom were analyzed | Posted | Mean | Standard Deviation | percentage | Up to 6 months of use |
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Subjects that used the Woman's Condom were analyzed | Posted | Mean | Standard Deviation | percentage | Up to 6 months of use |
|
6 months, immediately after informed consent has been obtained and lasts through the study Exit Visit, up to 6 months.
For this study, an Adverse Event (AE) is defined as one following: 1) any genital or urinary tract problem that lasts more than an hour, 2) any non-genital/urinary tract problem that is at least possibly related to condom use, or 3) a serious adverse event. The transient symptoms associated with the use of the study condom will not be reported as AEs. Those symptoms include irritation, itching, burning, rash, abnormal discharge (not including gel), odor, or pain or difficulty in urination.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 405 | 1 | 405 | 102 | 405 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Convulsion | Nervous system disorders | Systematic Assessment | Hospitalized for seizure |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal pain lower | Gastrointestinal disorders | Systematic Assessment |
| ||
| Cervicitis trichomonal | Infections and infestations | Systematic Assessment |
| ||
| Chlamydial infection | Infections and infestations | Systematic Assessment |
| ||
| Fungal infection | Infections and infestations | Systematic Assessment |
| ||
| Gonorrhoea | Infections and infestations | Systematic Assessment |
| ||
| Pelvic inflammatory disease | Infections and infestations | Systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Systematic Assessment |
| ||
| Vaginitis bacterial | Infections and infestations | Systematic Assessment |
| ||
| Vulvovaginal candidiasis | Infections and infestations | Systematic Assessment |
| ||
| Vulvovaginal mycotic infection | Infections and infestations | Systematic Assessment |
| ||
| Smear cervix abnormal | Investigations | Systematic Assessment |
| ||
| Convulsion | Nervous system disorders | Systematic Assessment |
| ||
| Dysuria | Renal and urinary disorders | Systematic Assessment |
| ||
| Micturition urgency | Renal and urinary disorders | Systematic Assessment |
| ||
| Pollakiuria | Renal and urinary disorders | Systematic Assessment |
| ||
| Stress urinary incontinence | Renal and urinary disorders | Systematic Assessment |
| ||
| Bartholin's cyst | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Dysmenorrhoea | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Dyspareunia | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Genital pain | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Menorrhagia | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Metrorrhagia | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Oedema genital | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Pelvic pain | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Vaginal discharge | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Vaginal disorder | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Vaginal haemorrhage | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Vaginal odour | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Vaginal swelling | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Vulval disorder | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Vulvovaginal burning sensation | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Vulvovaginal discomfort | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Vulvovaginal dryness | Reproductive system and breast disorders | Systematic Assessment |
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| Vulvovaginal pruritus | Reproductive system and breast disorders | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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Not provided
Not provided
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| Dr. Jill Long | NICHD Medical Officer | 301-496-1662 | jill.long@nih.gov |
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