Study of the Safety and Contraceptive Efficacy of C31G Compared to Conceptrol®
Condition: Pregnancy
Intervention: C31G; nonoxynol-9 (N-9)
Intervention description: The subject will insert one applicator of C31G prior to each episode of vaginal intercourse during her participation in the study.; 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.
Intervention MeSH terms: Nonoxynol
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 1565.0
Sex: Female
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: contraception

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

        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.

          -  Be at low-risk for human immunodeficiency virus (HIV) or sexually transmitted disease
             (STD) infection and currently have a single sex partner (minimum 4 months) who is also
             at low-risk for HIV or STD.

          -  Have a negative urine pregnancy test prior to enrollment.

          -  Have normal cyclic menses with a usual length of 24 to 35 days over the last 2 cycles
             or at least one spontaneous, normal menstrual cycle (2 menses) since delivery,
             abortion, or after discontinuing hormonal contraception/hormonal therapy.

          -  Be willing to accept a risk of pregnancy.

          -  Be willing to engage in at least 4 acts of heterosexual vaginal intercourse per month
             for a period of 6 months.

          -  Be willing to be randomized to either study treatment.

          -  Be willing to only use the study product as the primary method of contraception over
             the course of the study with the exception of emergency contraception (EC), when
             indicated.

          -  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 sign and symptom data of
             subject and partner.

          -  Agree not to participate in any other clinical trials during the course of the study.

          -  Be willing to give written informed consent to participate in the trial.

        Exclusion Criteria:

        Potential subjects must not:

          -  Have a history of allergy or sensitivity to spermicides or products containing N-9.

          -  Have had 3 or more urinary tract infections (UTI) in the past year.

          -  Have UTI by urine culture or symptomatic yeast vaginitis or symptomatic bacterial
             vaginosis diagnosed by wet mount unless treated and proof of cure is documented.

          -  Be pregnant, have a suspected pregnancy or desire to become pregnant during the course
             of the study.

          -  Have a history of infertility or of conditions that may lead to infertility, without
             subsequent intrauterine pregnancy.

          -  Have any contraindications to pregnancy (medical condition) or chronic use of category
             D or X medications.

          -  Have had more than one sexual partner in the last 4 months.

          -  Have shared injection drug needles within the past 12 months.

          -  Have or have been suspected to have HIV infection.

          -  Have been diagnosed with genital herpes simplex virus (HSV), with the first occurrence
             (initial episode) within three months prior to screening.

          -  Have 3 or more outbreaks of HSV within the last year.

          -  Have been diagnosed with any other STDs (including trichomonas) in the 6 months prior
             to the screening visit (with the exception of Human Papilloma Virus [HPV]).

          -  Be lactating or breastfeeding.

          -  Have any clinically significant abnormal vaginal bleeding or spotting within the month
             prior to screening.

          -  Have any clinically significant abnormal finding on pelvic examination or baseline
             labs, which in the view of the investigator, precludes her from participating in the
             trial.

          -  Have clinically significant signs of vaginal or cervical irritation on pelvic
             examination.

          -  Have had vaginal or cervical biopsy or vaginal surgery within 3 months prior to
             screening.

          -  Have used vaginal or systemic antibiotics or antifungals within 14 days prior to
             screening or randomization.

          -  Have had a Depo-Provera® injection in the 10 months prior to enrollment.

          -  Have an abnormal Pap smear with high grade squamous intraepithelial lesion (HSIL),
             atypical glandular cells (AGC) or ASC-H (atypical squamous cells, cannot exclude HSIL)
             within the last 12 months.

          -  Have an abnormal Pap smear with low-grade squamous intraepithelial lesion (LSIL) or
             ASCUS-HPV HR positive unless resolved by colposcopy.

          -  Have a Cervical Intraepithelial Neoplasia (CIN) diagnosis by biopsy within the last 12
             months.

          -  Have a history or a current diagnosis of cervical cancer.

          -  Consume (on average) greater than three drinks of an alcoholic beverage per day.

          -  Have a past history (within twelve months) or current history of drug abuse
             [recreational, prescription or over-the-counter (OTC)].

          -  Have taken an investigational drug or used an investigational device within the past
             30 days.

          -  Have previously participated in or completed this study or any other phase III study
             of C31G.

          -  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.