Status:
COMPLETED
Contraception and Menstrual Cycle Effect on Pharmacokinetics, Pharmacodynamics and Safety in Tenofovir Vaginal Gel Use
Lead Sponsor:
CONRAD
Conditions:
HIV Prevention
Eligibility:
FEMALE
18-50 years
Phase:
PHASE1
Brief Summary
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 contraceptiv...
Detailed Description
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 e...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT01421368
Start Date
March 1 2012
End Date
March 1 2014
Last Update
April 10 2015
Active Locations (3)
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1
University of Pittsburgh School of Medicine, Center for Family Planning Research
Pittsburgh, Pennsylvania, United States, 15213
2
Easter Virginia Medical School
Norfolk, Virginia, United States, 23507
3
Profamilia
Santo Domingo, Dominican Republic