Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2025-12-25 @ 12:02 AM
NCT ID:
NCT00065858
Eligibility Criteria:
Inclusion Criteria
* General good health
* Sexually active, at risk for pregnancy, and desiring contraception
* Low-risk for HIV or STD infection
* Single sexual partner who is at low-risk for HIV or STD infection for 6 months prior to study entry
* Expect to have same sexual partner for duration of the study
* Normal cyclic menses with a usual length of 21 to 35 days
* Documented history of at least two spontaneous, normal menstrual cycles since delivery, abortion, or after discontinuing hormonal contraception/hormonal therapy
* Willing to accept a risk of pregnancy
* Willing to engage in an average of 1 to 2 acts of heterosexual vaginal intercourse per week for a period of 6 months
* Willing to be fitted with a diaphragm and use the diaphragm with test product during all acts of heterosexual vaginal intercourse for the duration of the study
* Willing to only use the test product with diaphragm as the sole method of contraception over the course of the study (with the exception of emergency contraceptive pills when indicated)
* Capable of using the product and diaphragm properly
* 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 for self and partner
* Agree not to participate in any other clinical trials during the course of the study
* Written informed consent to participate in the trial
Participant's Sexual Partner Must Not Be/Have
* Infertile
* Treated for Chlamydia trachomatis or Neisseria gonorrhoeae in the 6 months prior to study entry
* HIV infected
* More than one sexual partner in the 4 months prior to study entry
* Engaged in homosexual intercourse
* Shared injection drug needles in the 6 months prior to study entry
* Allergy or sensitivity to spermicides or products containing Nonoxynol 9 or latex
Exclusion Criteria
* Pregnant or desire to become pregnant during the course of the study
* History of infertility or conditions that may lead to infertility
* Allergy or sensitivity to spermicides or products containing Nonoxynol 9 or latex
* History of toxic shock syndrome (TSS)
* Two or more urinary tract infections (UTIs) in the 12 months prior to study entry
* Current suspected or diagnosed urinary tract infection or vaginitis
* Contraindications to pregnancy (medical condition or chronic use of medications contraindicated for pregnancy)
* Treated with antibiotics for pelvic inflammatory disease (PID) without a subsequent intrauterine pregnancy
* More than one sexual partner in the 4 months prior to study entry
* Shared injection drug needles in the 6 months prior to study entry
* HIV infected or suspected HIV infection
* Genital herpes simplex virus (HSV) infection with the first occurrence (initial episode) within 3 months prior to study entry or have clinical evidence of HSV on exam
* Sexually transmitted diseases (STDs) in the 3 months prior to study entry
* Lactating or breastfeeding
* Abnormal vaginal bleeding or spotting in the month prior to study entry
* Lower abdominal or pelvic pain in the month prior to study entry
* Abnormal finding on pelvic examination which, in the view of the study investigator, precludes participation in study
* Vaginal or cervical irritation, including vaginal or cervical epithelial disruption, ulceration, bleeding, petechiae, sloughing, or areas of obvious erythema
* Vaginal or cervical biopsy or surgery in the 3 months prior to study entry
* Vaginal or systemic antibiotics, antivirals, or antifungals in the 14 days prior to study entry
* Depo-Provera injection in the 10 months prior to study
* Vaginal or cervical abnormality that would interfere with the proper placement and retention of test product and diaphragm
* Abnormal Pap smear in the 12 months prior to study entry
* Consume (on average) greater than 2 to 3 alcoholic beverages per day
* Drug abuse (recreational, prescription, or OTC) in the 12 months prior to study entry
* Investigational drug or device use in the month prior to study entry
* Previously participated in or completed this study
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT00065858
Study Brief:
Protocol Section:
NCT00065858