Impact of Contraceptives on Cervico-Vaginal Mucosa

Completed · Phase 4

Conditions studied: Mucosal Inflammation, Contraceptive; Complications, Intrauterine

In brief

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.

Key facts

Study ID

NCT04814927

Run by

Eastern Virginia Medical School

People needed

112

Starts

2021-03-01

Expected to finish

2022-12-15

Last updated by the study team

2023-08-25

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Eastern Virginia Medical School — Norfolk, Virginia, United States
• KEMRI — Thika, Central, Kenya

Full record on ClinicalTrials.gov

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