Impact of Contraceptives on Cervico-Vaginal Mucosa

Mucosal Inflammation Clinical Trial

— UMPALA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04814927
• Other study ID #: CONRAD D20-149
• Status: Completed
• Phase: Phase 4
• Start date: March 1, 2021
• Est. completion date: December 15, 2022

Study information

• Verified date: August 2023
• Source: Eastern Virginia Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: December 15, 2022
• Est. primary completion date: December 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Contraceptive; Complications, Intrauterine
• Inflammation
• Mucosal Inflammation
• Mucositis

Intervention

Drug:
• Copper IUD
Participants randomized to Copper IUD will receive Paragard IUD at Visit 2.
• Etonogestrel implant
Participants randomized to ETG implant will receive the implant at Visit 2.
• Levonorgestrel IUS
Participants randomized to LNG intrauterine system will receive the IUS at Visit 2.
• DMPA Sub-cutaneous
Participants randomized to DMPA SC will receive the injection at Visit 2.

Locations

Country	Name	City	State
Kenya	KEMRI	Thika	Central
United States	Eastern Virginia Medical School	Norfolk	Virginia

Sponsors (4)

Lead Sponsor	Collaborator
Eastern Virginia Medical School	CONRAD, Kenya Medical Research Institute, United States Agency for International Development (USAID)

Countries where clinical trial is conducted

United States,  Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mucosal susceptibility to pathogens	Model mucosal susceptibility to STIs ex vivo at baseline and after contraceptive use	4 weeks and 3 months after product use
Primary	Number of participants with changes to mucosal function	Evaluate mucosal factors and microbiome changes from baseline associated with mucosal function and reproductive health, including vaginal glycogen, pH, lactic acid, soluble markers and immune cells.	4 weeks and 3 months after product use
Primary	Number of participants with changes to mucosal health	Evaluate mucosal factors and microbiome changes from baseline associated with mucosal function and reproductive health, including vaginal glycogen, pH, lactic acid, soluble markers and immune cells.	4 weeks and 3 months after product use
Secondary	Number of participants with systemic inflammation	Evaluate changes from baseline in systemic factors associated with reproductive health, including C reactive protein and hormone concentrations.	4 weeks and 3 months after product use