Clinical trial NCT00274261 (phase 3, status: completed)
Conditions: pregnancy
ICD codes: O00.00, O00.01, O00.101, O00.102, O00.109, O00.111, O00.112
Drugs: c31g, nonoxynol-9 (n-9)
SMILES: CCCCCCCCCCCC[N+](C)(C)[O-].CCCCCCCCCCCC[N+](C)(C)CC([O-])=O, CCCCCCCCCC1=CC=C(OCCOCCOCCOCCOCCOCCOCCOCCOCCO)C=C1
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.