The purpose of the study is to examine the effects of two contraceptive methods and the
menstrual cycle on the pharmacokinetics, pharmacodynamics of tenofovir 1% gel and the effect
of the contraceptive methods on markers of mucosal safety.
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Female.
Inclusion Criteria:
- Willing and able to use OCs or DMPA
- General good health (by volunteer history and investigator assessment) without any
clinically significant systemic disease
- Currently having regular menstrual cycles of 25 to 35 days by volunteer report
- History of Pap smears and follow-up consistent with American Congress of
Obstetricians and Gynecologists (ACOG) practice bulletin #99 or #109 or willing to
undergo a Pap smear at Visit 1
- Willing to follow protocol requirements including abstinence, use of study condoms,
and prohibited use of intravaginal products
- Willing to follow post-biopsy restrictions for at least 5 days following genital
biopsies
- Meets one of the following criteria:
1. Sexually abstinent and planning to remain abstinent for the duration of the
study.
2. In a mutually monogamous relationship for at least the last 4 months with a male
partner who is at least 18 years of age, willing to use condoms, and has no
known HIV infection or risks for sexually transmitted infections (STIs)
3. In a mutually monogamous same-sex relationship for at least the last 4 months
with a partner who is at least 18 years of age and has no known HIV infection or
risks for STIs
- Vaginal and cervical anatomy that, in the opinion of the investigator, lends itself
to easy genital tract sample collection
- Negative urine pregnancy test
- Willing to give voluntary consent, sign an informed consent form and comply with
study procedures, as required by the protocol
Exclusion Criteria:
- History of hysterectomy
- Currently pregnant or within 2 calendar months from the last pregnancy outcome.
(Note: If recently pregnant must have had at least 2 spontaneous menses since
pregnancy outcome.)
- Use of any hormonal contraceptive method in the last 30 days (oral, transdermal,
transvaginal, implant, or hormonal intrauterine contraceptive device)
- Injection of DMPA in the last 6 months
- Protection from pregnancy by presence of a copper IUD
- Currently breastfeeding or having breastfed an infant in the last 2 months, or
planning to breastfeed during the course of the study
- History of sensitivity/allergy to any component of the study product, or topical
anesthetic, or allergy to both silver nitrate and Monsel's solution
- Diagnosed with or treated for any STI or pelvic inflammatory disease in the last 6
months. (Note: Women with a history of genital herpes or condylomata who have been
asymptomatic for at least 6 months may be considered for eligibility.)
- Positive test for Trichomonas vaginalis, Neisseria gonorrhoeae or Chlamydia
trachomatis
- Symptomatic vulvovaginal candidiasis, Nugent score greater than or equal to 7 at
screening or bacterial vaginosis (BV) at Visit 2, or urinary tract infection (UTI)
- Deep epithelial genital findings such as abrasions, ulcerations, or lacerations, or
vesicles suspicious for STIs
- Positive test for HIV
- Positive test for Hepatitis B surface antigen (HBsAg)
- Known bleeding disorder that could lead to prolonged or continuous bleeding with
biopsy
- Chronic or acute vulvar or vaginal symptoms (e. g., pain, irritation, or spotting)
- Contraindications to the chosen contraceptive method
- Known current drug or alcohol abuse which could impact study compliance
- Grade 1 or higher laboratory abnormality, per the August 2009 update of the DAIDS
Table for Grading the Severity of Adverse Events
- Participation in any other investigational trial (device, drug, or vaginal trial) in
the last 30 days or planned participation in any other investigational trial during
the study
- History of gynecological procedures (including genital piercing) on the external
genitalia, vagina or cervix in the last 14 days
- Abnormal finding on laboratory or physical examination or a social or medical
condition which, in the opinion of the investigator, would make participation in the
study unsafe or would complicate interpretation of data
- Systemic use in the last two weeks or anticipated use during the study of any of the
following: corticosteroids, antibiotics, antifungals, antivirals or antiretrovirals