The UMPALA Study: A Clinical Study to Assess the Impact of Contraceptives on the Cervico-Vaginal Mucosa

CONRAD D20-149

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.

2021-03-01

2022-12-15

2022-12-15

Completed

Early phase I

112

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants at each site will receive one of four marketed, approved contraceptive products for the duration of the study.', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 112, 'type': 'ACTUAL'}}

2023-08-25