Impact of Contraceptives on Cervico-Vaginal Mucosa

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2022-12-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Endometrial Effects of Lipiodol

NCT03542331

Female Infertility

UNKNOWN PHASE3

Impact of Essure Tubal Sterilization Devices on the Endometrium

NCT01558882

Sterilization, Tubal

TERMINATED

Can Intrauterine Levonorgestrel Releasing Device Be a Treatment Option for Postmenstrual Spotting in Isthmocele

NCT04872244

Isthmocele Post-menstrual Spotting Bleeding Pelvic Pain

COMPLETED NA

Efficacy of Dead Sea Peloid Gel in Chronic Endometritis

NCT02680275

Chronic Endometritis

COMPLETED NA

Levonorgestrel-Releasing Intrauterine System (LNG-IUS) in the Management of Atypical Endometrial Hyperplasia

NCT04897217

Endometrial Hyperplasia

WITHDRAWN PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mucosal Inflammation Contraceptive; Complications, Intrauterine

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Copper IUD

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.

Group Type ACTIVE_COMPARATOR

Copper IUD

Intervention Type DRUG

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

Etonogestrel Implant

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.

Group Type ACTIVE_COMPARATOR

Etonogestrel implant

Intervention Type DRUG

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

Levonorgestrel IUS

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

Group Type ACTIVE_COMPARATOR

Levonorgestrel IUS

Intervention Type DRUG

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

DMPA Sub-cutaneous

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.

Group Type ACTIVE_COMPARATOR

DMPA Sub-cutaneous

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Copper IUD

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

Intervention Type DRUG

Etonogestrel implant

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

Intervention Type DRUG

Levonorgestrel IUS

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

Intervention Type DRUG

DMPA Sub-cutaneous

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Paragard Nexplanon Implanon Mirena Liletta Subcutaneous depot medroxyprogesterone acetate

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes