impact of contraceptives on cervico-vaginal mucosa

Conditions: Mucosal Inflammation; Contraceptive; Complications, Intrauterine

Summary: umpala is a research study to look at the effect of four different, approved contraceptives on the cervical and vaginal tissues as well as on factors in the blood. participants will have a baseline examination then receive one of four approved, marketed contraceptive products. cervico-vaginal assessments will take place 4 weeks after contraceptive initiation and 3 months after to assess changes in mucosal safety after use of various contraceptive products in young, healthy, hiv uninfected women.

this clinical study will complete approximately 12 healthy, non-pregnant, hiv-uninfected women aged 18-50 years per contraceptive arm, who are at low risk for sexually transmitted infections (stis) at two clinical sites, for a total of approximately 96 completed participants. the study will examine changes from baseline, pre-contraceptive dosing to post contraceptive dosing of cervico-vaginal mucosal safety and adverse events. participants at each site will be randomized (1:1:1:1) to one of four, marketed, approved contraceptive dosing forms: levonorgestrel (lng) 52 mg. intrauterine system (ius), copper intrauterine device (iud), etonogestrel (etg, nexplanon, implanon) contraceptive implant, or dmpa sc contraceptive injection. enrollment is expected to take approximately 8 months and each participant is expected to complete the study within 4 months.

Eligibility criteria:
inclusion criteria: * age 18 to 50 years, inclusive * in general good health without any significant systemic disease and with an intact uterus and cervix. * history of pap smears and follow-up consistent with standard, local clinical practice or willing to undergo a pap smear at visit 1 * willing to give voluntary consent and sign an informed consent form * willing and able to comply with protocol requirements, including accepting randomization to study contraceptive products * if currently on a contraceptive product, willing to go off products and use condoms for birth control for a specified time * if in a relationship, must be with a partner who is not known to be hiv positive and has no know risk of sexually transmitted infections (stis) exclusion criteria: * positive pregnancy test or plans to become pregnant during the course of the study * currently exclusively breastfeeding or planning to exclusively breastfeed during the course of the study * less than six weeks from a delivery of an infant greater than 20 weeks gestation * use of dmpa in the past 4 months * clinical signs and symptoms of menopause * current who or cdc medical eligibility criteria level 3 or 4 for any contraceptive product to which a participant could receive at the clinical site * history of sensitivity/allergy to any component of the study product, topical anesthetic, or to both silver nitrate and monsel's solution * current infection with trichomonas vaginalis (tv), neisseria gonorrhea (ng), chlamydia trachomatis (ct) * current positive test for hiv * history of a pulmonary embolus or deep vein thrombosis * chronic or acute vulvar or vaginal symptoms (pain, irritation, spotting/bleeding, discharge, etc) * known blood disorder, eg. von willebrands disease, that could lead to prolonged or continuous bleeding with biopsy * chronic use systemic corticosteroids, antibiotics, antimycobacterials, anticoagulants or other drugs known to prolong bleeding and/or promote clotting, antifungals, or antivirals or antiretrovirals. * current or anticipated chronic use of non-steroidal anti-inflammatory drugs (nsaids) or acetaminophen for the duration of the study * participation in any other investigational trial with use of a drug/device within the last 30 days or planned participation in any other investigational trial with use of a drug/device during the study * abnormal finding on laboratory or physical examination or a social or medical condition in which, in the opinion of the investigator, would make participation in the study unsafe or would complicate interpretation of the data

Keywords: contraception reproductive health copper iud etonogestrel implant dmpa sub-cutaneous levonorgestrel ius