A Multicenter, Open-Label, Randomized Study of the Contraceptive Efficacy and Safety of Amphora™ Gel Compared to Conceptrol® Vaginal Gel
This is a multicenter, open-label, randomized, controlled, phase III study of repeated use of Amphora(TM) gel compared to Conceptrol(TM) Vaginal Gel as the method of contraception over seven cycles of use. In addition, there is an opportunity for Amphora(TM) gel subjects to continue with study treatment for up to 13 cycles of treatment upon completion of the first seven cycles of treatment.
A subset of subjects (Amphora(TM) gel and Conceptrol(TM) Vaginal Gel) will undergo colposcopy at the Admission Visit and at the visits after Cycles 1, 3, and 7 (Treatment Exit). Subjects participating for 13 cycles will also undergo colposcopy after Cycles 10 and 13. Colposcopic photographs will be taken of all suspicious areas and clinical findings recorded on the colposcopy case report form. The colposcopy evaluator for the subset will be blinded regarding the treatment group of the subject. If at any time during the study the investigator deems colposcopy necessary, colposcopy will be performed on any subject and will not be limited to subjects in the colposcopy subset.
A subset of subjects (Amphora(TM) gel and Conceptrol(TM) Vaginal Gel) will also have semi-quantitative cultures for E. coli and clinical yeast performed at the Admission Visit and after Cycles 1, 3, and 7 (Treatment Exit) Visits. Subjects participating for 13 cycles will also undergo the assessments after Cycles 10 and 13. Another subgroup will have quantitative vaginal cultures performed after Cycles 1, and 7 (Treatment Exit) Visits, and also after Cycle 13 for subjects participating in the extension.
1. Be healthy women, who are sexually active, at risk for pregnancy, and desiring
2. Be within the age range of 18 through 35 (inclusive) at enrollment if not in the subset
of women with an age of 36-45 at enrollment (age subset at select sites).
3. Be at low-risk for both human immunodeficiency virus (HIV) and sexually transmitted
disease (STD) infection and currently have a single male sex partner (≥ 4 months)
who is also at low-risk for both HIV and STD infection.
4. Have a negative urine pregnancy test prior to enrollment.
5. Have regular, normal, cyclic menses with a usual length of 21 to 40 days over the
last two cycles or at least one spontaneous, normal menstrual cycle (consisting of
two menses 21 to 40 days apart) since delivery, abortion (spontaneous or induced),
or after discontinuing hormonal contraception or hormonal therapy.
6. Be willing to accept a risk of pregnancy.
7. Be willing to engage in at least two acts of heterosexual vaginal intercourse per
8. Be willing to be randomized to either study treatment.
9. Be willing to use the study product as the only method of contraception over the
course of the study (with the exception of emergency contraception (EC), when
10. Be capable of using the study product properly and agree to comply with all study
directions and requirements.
11. Be willing to keep a daily diary to record coital information, product use information,
information about the use of other vaginal products, and sign and symptom data for
both the subject and her partner.
12. Agree not to participate in any other clinical trials during the course of the study.
13. Be capable and willing to give written informed consent to participate in the trial.