Randomized Comparative Study of the Contraceptive Efficacy of the Cupid, Cupid 2 and FC2 Female Condom
Randomized Comparative Study of the Contraceptive Efficacy of the Cupid, Cupid 2 and FC2 Female Condom
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.
This research study aims to assess the effectiveness of three female condoms (Cupid, Cupid 2
 and FC2) for the prevention of pregnancy among women choosing the female condom (FC) as their
 method of fertility regulation.

 The study is a randomized comparative prospective follow-up study. 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. The primary endpoint will be the
 occurrence of pregnancy or use of emergency contraception, and the diary information will
 allow pregnancy rates to be characterized by patterns of condom use and failures
 (contraceptive efficacy and effectiveness rates).

 The target population will be 780 urban and peri urban, sexually active women who are
 experienced users of FCs. Recruitment will be from a family planning clinic associated with
 the MatCH Research Unit (MRU), University of the Witwatersrand, Durban, South Africa and the
 surrounding community. The woman rather than the couple will be the unit of observation since
 the major outcome to be measured is pregnancy. There will be monthly follow-ups of
 participants from enrollment until after the 6th menstrual cycle (month 1,2,3,4,5 and 6). All
 visits will be conducted at the research site. The diary, to be completed on a daily basis by
 the participants, will indicate whether the coital frequency differs significantly between
 subgroups (students, urban, peri-urban).

 Female clients of the Commercial City Clinic and other women presenting at the site will be
 informed about the study. If a potential participant expresses interest in participating, she
 will be given the study information sheet to read, which will describe the study requirements
 and her potential role in the study. If she agrees to take part in the research, she will be
 asked to provide written informed consent. The participant will be administered the screening
 form to determine whether she meets study inclusion criteria.

 Eligible women who agree to participate will undergo a baseline interview. Information
 collected during the enrollment interview will include demographic data and information on
 the participant's general and reproductive health. The data collected on reproductive health
 variables will include the date of last menstrual period (LMP), history of pregnancies,
 births and miscarriages, a contraceptive history as well as a sexual history. After
 completion of the interview, the participant will be randomized to the use on one FC type.

 Male partners will not be asked to sign an Informed Consent as they will not be required to
 participate in the research, but female participants will be given an additional information
 sheet if they desire to give to the male partner to tell them about the study.

 If a potential participant does not wish to be enrolled, she will be provided with referral
 (should she wish) for any reproductive health services according to normal clinical practice
 at the study site. Her reasons will be recorded on the log of refusals. This information will
 be used to compile statistics on the participation rates and reasons for nonparticipation.

 Although all study participants are required to have ever used a FC, some may have not used
 the FC they have been randomized to and have experience with other FC types. All participants
 will be retrained regardless of previous FC use using a pelvic model. The study staff will
 demonstrate FC insertion and train the participants in the proper use of the randomized FC
 type. Further, they will provide instruction on how to complete the condom use log and the
 study diary. She will also receive instructions on use in her preferred language (English or
 Zulu).

 The participants will be given their first study packet which will contain either Cupid,
 Cupid 2 or FC2 with a diary for the first month of the study. Research staff will discuss
 with the participant how many condoms they require for the month. The participants will be
 instructed how to complete the diary card. The first follow-up visit should occur
 approximately one month after enrollment and should be pre-scheduled. The date of the first
 follow-up visit should be written in an appointment card and on the designated location on
 the Condom diary card. Participants who finish using their condoms prior to their scheduled
 follow-up visit, will be encouraged to contact MRU for a resupply.

 There will be six follow-up visits in person at 1, 2, 3, 4, 5, and 6 months. Telephonic
 follow-up will be conducted between 7-14 days post enrollment to confirm any queries or
 problems in use of condoms or diaries.

 Participants will be administered a follow-up survey about their experiences using their
 randomized FC, whether there has been a delay in expected onset of menses, the date of last
 menstrual period, and information on the use of other contraceptives since the last visit.
 The daily diary will also be reviewed at each visit for completeness and accuracy. A
 pregnancy test will be carried out at every on-site visit. Any reported or confirmed
 pregnancies will include counseling and referral to an antenatal or other healthcare
 facility. The final follow up visit will be scheduled after 6th menstrual cycle.

 Women will be discontinued from the study at any stage during follow-up for: pregnancy,
 unwillingness to continue use of FCs or change to a non-study contraceptive method as her
 main contraceptive method, or refusal to be followed up.

 Block randomization will be used. A statistician (not otherwise involved in this study) will
 develop the random allocation sequence using a validated statistical program in Stata
 (StataCorp LP, College Station, Texas, USA). Use-order assignments will be generated via the
 RedCap electronic program. The statistician will be blinded until all data have been captured
 and the primary analysis programs have been verified. Due to dissimilarities of the study
 products, it will not be possible to blind participants and clinic staff associated with the
 project.
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.