Contraception and Menstrual Cycle Effect on Pharmacokinetics, Pharmacodynamics and Safety in Tenofovir Vaginal Gel Use

Completed · Phase 1 · Has a placebo group

Conditions studied: HIV Prevention

In brief

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.

Key facts

Study ID

NCT01421368

Run by

CONRAD

People needed

72

Starts

2012-03-01

Expected to finish

2014-03-01

Last updated by the study team

2015-04-10

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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:
• Sexually abstinent and planning to remain abstinent for the duration of the study.
• 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)
• 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

You may not qualify if…

• 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

Where it is running

• University of Pittsburgh School of Medicine, Center for Family Planning Research — Pittsburgh, Pennsylvania, United States
• Easter Virginia Medical School — Norfolk, Virginia, United States
• Profamilia — Santo Domingo, Dominican Republic

Full record on ClinicalTrials.gov

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