Impact of Contraceptives on Cervico-Vaginal Mucosa

NCT04814927 | Completed Phase 4 FDA Drug

• 1 other identifier: CONRAD D20-149
• Study Type: interventional
• Target: 112
• Locations: 2 countries
• Sites: 2

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.

Conditions

Mucosal Inflammation; Contraceptive; Complications, Intrauterine

Keywords

Contraception; Reproductive health; Copper IUD; Etonogestrel implant; DMPA sub-cutaneous; Levonorgestrel IUS

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Number of participants with systemic inflammation

  4 weeks and 3 months after product use

Other Outcomes (1)

• Mucosal susceptibility to pathogens

  4 weeks and 3 months after product use

Study Arms (4)

Copper IUD

ACTIVE COMPARATOR

The copper IUD contains approximately 176 mg of copper wire wrapped around a vertical stem. It is FDA approved for pregnancy prevention for 10 years.

Drug: Copper IUD

Etonogestrel Implant

ACTIVE COMPARATOR

The ETG implant is a single, radiopaque, rod shaped implant containing 68 mg of etonogestrel. It is FDA approved for pregnancy prevention for 3 years.

Drug: Etonogestrel implant

Levonorgestrel IUS

ACTIVE COMPARATOR

The LNG IUS contains approximately 52 mg. of LNG. It is FDA approved for pregnancy prevention for 5 - 6 years.

Drug: Levonorgestrel IUS

DMPA Sub-cutaneous

ACTIVE COMPARATOR

DMPA contains 104 mg of medroxyprogesterone acetate in 0.65 mL of fluid, administered by subcutaneous injection in the abdominal fat, thigh or skin over the deltoid muscle. It is FDA approved for pregnancy prevention for 14 weeks.

Drug: DMPA Sub-cutaneous

Interventions

Copper IUD DRUG

Participants randomized to Copper IUD will receive Paragard IUD at Visit 2.

Also known as: Paragard

Copper IUD

Etonogestrel implant DRUG

Participants randomized to ETG implant will receive the implant at Visit 2.

Also known as: Nexplanon, Implanon

Etonogestrel Implant

Levonorgestrel IUS DRUG

Participants randomized to LNG intrauterine system will receive the IUS at Visit 2.

Also known as: Mirena, Liletta

Levonorgestrel IUS

DMPA Sub-cutaneous DRUG

Participants randomized to DMPA SC will receive the injection at Visit 2.

Also known as: Subcutaneous depot medroxyprogesterone acetate

DMPA Sub-cutaneous

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Eastern Virginia Medical School: lead
• CONRAD: collaborator
• Kenya Medical Research Institute: collaborator
• United States Agency for International Development (USAID): collaborator

Study Sites (2)

Eastern Virginia Medical School

Norfolk, Virginia, 23507, United States

Location

KEMRI

Thika, Central, 01000, Kenya

Location

MeSH Terms

Conditions

Mucositis

Interventions

Intrauterine Devices, Copper; etonogestrel; Levonorgestrel

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Intrauterine Devices, Medicated; Intrauterine Devices; Contraceptive Devices, Female; Contraceptive Devices; Equipment and Supplies; Norgestrel; Norpregnenes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Andrea Thurman

  Eastern Virginia Medical School, CONRAD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants at each site will receive one of four marketed, approved contraceptive products for the duration of the study.

Study Record Dates

• First Submitted: March 18, 2021
• First Posted: March 24, 2021
• Study Start: March 1, 2021
• Primary Completion: December 15, 2022
• Study Completion: December 15, 2022
• Last Updated: August 25, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

KE (1); US (1)