Impact of Contraceptives on Cervico-Vaginal Mucosa

• Status: Recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Eastern Virginia Medical School
• Collaborators: CONRAD; Kenya Medical Research Institute; United States Agency for International Development (USAID)
• Treatments: Copper; Etonogestrel; Levonorgestrel; Medroxyprogesterone; Medroxyprogesterone Acetate

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