SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT00274261

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

A Phase II/III Multicenter, Randomized, Double-masked, Study of the Safety and Contraceptive Efficacy of C31G Compared to Conceptrol®

This is a multicenter, randomized, double-masked, controlled, phase III study of repeated use of C31G vaginal gel compared to Conceptrol® Vaginal Gel as the primary method of contraception over six months (183 days) and at least six cycles of use. In addition, there is an opportunity for subjects to continue with study treatment for up to twelve months (365 days) and twelve cycles of treatment upon completion of the first six months of treatment.

NCT00274261 Pregnancy

2 Interventions

Name: C31G

Description: The subject will insert one applicator of C31G prior to each episode of vaginal intercourse during her participation in the study.

Type: Drug

A

Name: nonoxynol-9 (N-9)

Description: The subject will insert one applicator of Conceptrol® vaginal gel (nonoxynol-9) prior to each episode of vaginal intercourse during her participation in the study.

Type: Drug

B


Primary Outcomes

Description: Number of pregnancies in women using C31G gel for 6 months (183 days) compared to women using Conceptrol gel for the same time frame.

Measure: The Cumulative Probability of Typical-use 6 Month (183 Days) Pregnancy.

Time: 6 months

Secondary Outcomes

Description: Evaluated by comparing the incidence of Adverse Events (AEs) among subjects using their assigned treatment for at least one day.

Measure: Incidence of Adverse Events.

Time: duration of the study - through 6 month or 12 months of use

Purpose: Prevention

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 C31G

A Phase II/III Multicenter, Randomized, Double-masked, Study of the Safety and Contraceptive Efficacy of C31G Compared to Conceptrol®. --- C31G ---

Study of the Safety and Contraceptive Efficacy of C31G Compared to Conceptrol® This is a multicenter, randomized, double-masked, controlled, phase III study of repeated use of C31G vaginal gel compared to Conceptrol® Vaginal Gel as the primary method of contraception over six months (183 days) and at least six cycles of use. --- C31G ---

Study of the Safety and Contraceptive Efficacy of C31G Compared to Conceptrol® This is a multicenter, randomized, double-masked, controlled, phase III study of repeated use of C31G vaginal gel compared to Conceptrol® Vaginal Gel as the primary method of contraception over six months (183 days) and at least six cycles of use. --- C31G --- --- C31G ---

The Cumulative Probability of Typical-use 6 Month (183 Days) Pregnancy.. Number of pregnancies in women using C31G gel for 6 months (183 days) compared to women using Conceptrol gel for the same time frame.. Incidence of Adverse Events.. Evaluated by comparing the incidence of Adverse Events (AEs) among subjects using their assigned treatment for at least one day.. Inclusion Criteria: Potential subjects must: - Be healthy women, who are sexually active, at risk for pregnancy and desiring contraception. --- C31G ---

- Have previously participated in or completed this study or any other phase III study of C31G. --- C31G ---

C31G is an effective spermicide with in vitro activity equal to that of N-9 . --- C31G ---

C31G has been found to be a broad-spectrum antibacterial agent in vitro or in animals, active against both gram-positive and gram-negative organisms, including chlamydia, and a range of antibiotic resistant strains. --- C31G ---

Thus, the primary objective of the study is to determine the contraceptive efficacy of C31G vaginal gel compared to Conceptrol® Vaginal Gel. --- C31G ---

Additional evaluations include the incidence of urinary tract infections (UTI), bacterial vaginosis (BV) and yeast vaginitis following the use of C31G vaginal gel compared to Conceptrol® Vaginal Gel. --- C31G ---



HPO Nodes