Study of UC-781 Vaginal Microbicide
Completed · Phase 1 · Has a placebo group
Conditions studied: HIV Infections
In brief
This study will help determine whether the agent UC-781, formulated as a gel, is safe when applied to the vagina twice daily for 14 days. It will also assess whether women find the gel acceptable to use.
Key facts
- Study ID
- NCT00132444
- Run by
- CONRAD
- People needed
- 90
- Starts
- 2005-10-01
- Expected to finish
- 2008-12-01
- Last updated by the study team
- 2010-01-07
Who can join
Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- For All Females:
- Ages 18-45 years of age
- Able to provide written informed consent
- Normal Pap smear at screening or documentation of such within six months prior
- Regular monthly menses or amenorrhea due to hormonal contraceptive use
- Agree to pelvic exam, colposcopy and biopsy (if indicated) per protocol
- Able/willing to complete Study Diary
- Agree to abstain from sexual intercourse for 48 hours prior to the enrollment visit
- Agree to apply assigned study gel as required per protocol
- Agree to abstain from the following activities from at least 48 hours prior to enrollment through the Day 14 visit:
- Insertion of fingers/objects into the vagina
- Receiving oral sex
- Receiving anal sex
- Using a diaphragm, cervical cap, female condom, or vaginal contraceptive ring
- Using vaginal products other than the study gels
- Participating in other vaginal microbicide or contraceptive studies
- Additional Inclusion Criteria for Stage 1:
- HIV-uninfected
- In a monogamous sexually active relationship with one male partner throughout the study
- Report having vaginal intercourse only with that partner at least two times per week
- Agree to use study-provided male condoms for each act of vaginal intercourse while taking part in the study
- Agree to inform male partner about participation
- Additional Inclusion Criteria for Stage 2:
- HIV-infected
- Sexually abstinent or agree to abstain from sexual intercourse while taking part in the study
You may not qualify if…
- Exclusion Criteria for All Females:
- Are post-menopausal
- Have had a hysterectomy
- Clinically significant chronic medical condition (other than HIV) that is considered progressive.
- History of malignancy, with the exception of basal cell or squamous cell skin cancer
- Pregnant or planning to become pregnant in the next three months
- Currently breastfeeding
- History of sensitivity or allergy to latex or any compound used in this study
- Have received antibiotics in the 14 days prior to enrollment
- Have used a spermicide or spermicidally lubricated condom within 7 days prior to enrollment
- Have been using a hormonal contraceptive method for less than 3 months prior to enrollment
- Have participated in other microbicide or contraceptive studies in the past three months
- Grade 3 or higher liver, renal or hematology abnormality, as defined by the Table for Grading the Severity of Adult Adverse Events at screening
- Have a positive bacterial urine culture
- Currently have a clinically detectable genital abnormality (i.e. vulvar, vaginal, cervical and/or perineal ulcer or lesions or abnormal Pap smear)
- In the three months prior to enrollment have had any of the following:
- An abnormal Pap smear
- A pregnancy
- An abortion
- An intrauterine device (IUD)
- Breakthrough menstrual bleeding
- Vaginal bleeding during or following vaginal intercourse
- Gynecologic surgery
- Signs consistent with a sexually transmitted disease (STD)
- Signs of genital trauma
Where it is running
- Hope Clinic of Emory University — Decatur, Georgia, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.