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

Launched by CONRAD · Aug 19, 2011

Keywords

ClinConnect Summary

Each woman will be seen in 6 visits and will be contacted by two scheduled follow-up telephone calls/visits. Volunteers will be consented at Visit 1 and undergo procedures to assess whether they are eligible to continue in the study. At Visit 2 (cycle days 20-25), after it has been confirmed that the participant meets all of the inclusion criteria and none of the exclusion criteria, genital samples will be taken and she will be given 2 applicators of tenofovir 1% gel to insert two hours apart. She will be instructed to return for Visit 3, approximately 3 or 11 hours after insertion of the s...

Gender

FEMALE

Eligibility criteria

• 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