Pregnancy Prevention Clinical Trial
Official title:
Randomized Comparative Study of the Contraceptive Efficacy of the Cupid, Cupid 2 and FC2 Female Condom
Verified date | January 2022 |
Source | University of Witwatersrand, South Africa |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This research study aims to assess the effectiveness of three female condoms [Cupid, Cupid 2 and Female Condom 2(FC2)] for the prevention of pregnancy among women choosing the female condom (FC) as their method of fertility regulation. Participants will be followed-up monthly for up to seven months. A daily diary will be used to record menstrual pattern, acts of intercourse and details of condom usage.
Status | Completed |
Enrollment | 400 |
Est. completion date | November 10, 2021 |
Est. primary completion date | November 10, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility | Inclusion Criteria: 1. Healthy sexually active women who have ever used an FC and using condoms (male or female) as their current method of contraception. 2. Be 18 to 40 years at enrolment (inclusive). 3. Have a negative urine pregnancy test at enrolment visit. 4. Is HIV negative 5. Have a history of regular cyclic menses (usual length of 21 to 35 days) when not using hormonal contraception. 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. Reporting to have 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 (Cupid or FC2 female condom) 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 daily diary to record menstrual pattern, acts of intercourse, and details of condom use and any condom failures. 13. Be willing to state that, to her best knowledge, her sexual partner: - Has not had a vasectomy or been previously diagnosed as infertile. - Is HIV negative - Has no known history of allergy or sensitivity to natural rubber latex, water-based or silicone lubricants - Does not want her to become pregnant in the next 7 months 14. Agree to have fingerprint identity check 15. Be willing to give written informed consent to participate in the trial. 16. Intend to stay in the area for the next 6-7 months 17. Be willing to be randomized Exclusion Criteria: 1. Have a history of allergy or sensitivity to rubber latex or water-based /silicone lubricants 2. Have evidence of sexually transmitted infections on syndromic assessment and / or vaginal examination 3. Be pregnant, have a suspected pregnancy or desire to become pregnant during the course of the study. 4. Have a history of infertility or pelvic inflammatory disease without a subsequent spontaneous intrauterine pregnancy. 5. Have been diagnosed with pelvic inflammatory disease (PID) without a subsequent intrauterine pregnancy. 6. Be in a monogamous relationship of less than 4 months with their partner. 7. Have any contraindications to pregnancy (medical condition) or regularly use medications that are unsafe to use in pregnancy 8. Have shared injection drug needles in the past unless has a negative HIV test at least 6 weeks since last use. 9. HIV positive. 10. 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. 11. Be lactating or breastfeeding. 12. Have any clinically significant abnormal vaginal bleeding or spotting within the month prior to screening. 13. Have had vaginal or cervical biopsy or vaginal surgery within 3 months prior to screening. 14. Have used vaginal or systemic antibiotics or antifungal agents within 14 days prior to screening or enrollment. 15. Have received a Depo-Provera® injection in the 6 months prior to enrolment or Nur-Isterate in the last 4 months prior to enrolment 16. Have a past (within 12 months) or current history of alcohol or drug [recreational, prescription or over-the-counter (OTC)] abuse. 17. Have taken an investigational drug or used an investigational device within the past 30 days. 18. 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. |
Country | Name | City | State |
---|---|---|---|
South Africa | MatCH Research Unit [Maternal, Adolescent and Child Health Research Unit] | Durban | Kwa-Zulu Natal |
Lead Sponsor | Collaborator |
---|---|
Prof Mags Beksinska |
South Africa,
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* Note: There are 20 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pregnancy | The main outcome measure of the study is the occurrence of pregnancy, which will be used to estimate the overall effectiveness of the method. For the overall pregnancy rate all pregnancies will be counted regardless of the reason(s) for the failure. Pregnancy rates will be computed using life table techniques. If the pregnancy rates are reasonably constant with time, then the Pearl index (pregnancies per 100 years of use) will be used and confidence intervals estimated from the Poisson distribution. Discrete time life-table methods will be used to explore patterns of failures associated with correct, incorrect and non-use of condoms (in each interval subjects will be classified according to the type or pattern of condom use and the life-table or Pearl rates computed for each stratum). Failure modes associated with the use of the female condoms per act of intercourse in which a FC was used. | 6-7 months | |
Secondary | Clinical breakage | Clinical breakage is defined as breakage during sexual intercourse or during withdrawal of the female condom from the vagina. Clinical breakage is breakage with potential adverse clinical consequences. The clinical breakage rate is calculated by dividing the number of female condoms reported to have broken during sexual intercourse or during withdrawal by the number of female condoms used during sexual intercourse. | 6-7 months | |
Secondary | Non-clinical breakage | Non-clinical breakage is breakage noticed before intercourse or occurring after withdrawal of the condom from the vagina (no potential adverse clinical consequences). | 6-7 months | |
Secondary | Total breakage | Total breakage is defined as the sum of all female condom breakages at any time before, during or after sexual intercourse. It includes both clinical breakages and non-clinical breakages. The total breakage rate is calculated by dividing the total number of female condoms that broke by the number of female condom packages opened. | 6-7 months | |
Secondary | Slippage | Slippage is defined as an instance when a female condom that slips completely out of the vagina during sexual intercourse. The slippage rate is calculated by dividing the number of female condoms that slipped by the number of female condoms used during sexual intercourse. | 6-7 months | |
Secondary | Misdirection | Misdirection is defined as vaginal penetration whereby the penis is inserted between the female condom and the vaginal wall. The misdirection rate is calculated by dividing the number of reported events of misdirection by the number of female condoms used during sexual intercourse. | 6-7 months | |
Secondary | Invagination | Invagination is defined as an instance when the external retention feature of the female condom is partially or fully pushed into the vagina during sexual intercourse. The invagination rate is calculated by dividing the number of events of invagination by the number of female condoms used during sexual intercourse. | 6-7 months | |
Secondary | Total clinical failure | Total clinical failure is defined as the sum of female condoms that clinically break or slip, or are associated with misdirection, invagination or any additional failure modes(s) identified in the risk assessment which results in the reduction of the female condom protective function. The total clinical failure rate is calculated by dividing the number of female condoms with a clinical failure by the number of female condoms used during sexual intercourse. | 6-7 months | |
Secondary | Total female condom failure | Total female condom failure is defined as a female condom for which a non-clinical breakage, clinical breakage or slippage occurs, or is associated with misdirection, invagination or any additional failure modes(s) identified in the risk assessment. The female condom failure rate is calculated by dividing the number of female condoms that fail by the number of female condom packages opened. | 6-7 months |
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