Clinical trial NCT04814927: Impact of Contraceptives on Cervico-Vaginal Mucosa
Official title: The UMPALA Study: A Clinical Study to Assess the Impact of Contraceptives on the Cervico-Vaginal Mucosa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Mucosal Inflammation
Contraceptive; Complications, Intrauterine
Keywords: Contraception
Reproductive health
Copper IUD
Etonogestrel implant
DMPA sub-cutaneous
Levonorgestrel IUS
Lead sponsor: Eastern Virginia Medical School
Sponsor class: OTHER
Collaborators: name: CONRAD
name: Kenya Medical Research Institute
name: United States Agency for International Development (USAID)
First posted: 2021-03-24
Enrollment: 112
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants at each site will receive one of four marketed, approved contraceptive products for the duration of the study.
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed description: 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

Primary outcomes:
measure: Number of participants with changes to mucosal function
timeFrame: 4 weeks and 3 months after product use
measure: Number of participants with changes to mucosal health
timeFrame: 4 weeks and 3 months after product use
Secondary outcomes:
measure: Number of participants with systemic inflammation
timeFrame: 4 weeks and 3 months after product use
Other outcomes:
measure: Mucosal susceptibility to pathogens
timeFrame: 4 weeks and 3 months after product use
Locations:
city: Norfolk
country: United States
facility: Eastern Virginia Medical School
state: Virginia
city: Thika
country: Kenya
facility: KEMRI
state: Central
Study officials:
affiliation: Eastern Virginia Medical School, CONRAD
name: Andrea Thurman
role: PRINCIPAL_INVESTIGATOR
References: