- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04814927
Impact of Contraceptives on Cervico-Vaginal Mucosa (UMPALA)
The UMPALA Study: A Clinical Study to Assess the Impact of Contraceptives on the Cervico-Vaginal Mucosa
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Andrea Thurman, MD
- Phone Number: 757.446.8931
- Email: thurmaar@evms.edu
Study Contact Backup
- Name: Karen Dominguez, MPH
- Email: domingk@evms.edu
Study Locations
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Central
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Thika, Central, Kenya, 01000
- KEMRI
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Virginia
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Norfolk, Virginia, United States, 23507
- Eastern Virginia Medical School
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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.
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Participants randomized to Copper IUD will receive Paragard IUD at Visit 2.
Other Names:
|
Active Comparator: 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.
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Participants randomized to ETG implant will receive the implant at Visit 2.
Other Names:
|
Active Comparator: Levonorgestrel IUS
The LNG IUS contains approximately 52 mg. of LNG.
It is FDA approved for pregnancy prevention for 5 - 6 years.
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Participants randomized to LNG intrauterine system will receive the IUS at Visit 2.
Other Names:
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Active Comparator: 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.
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Participants randomized to DMPA SC will receive the injection at Visit 2.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with changes to mucosal function
Time Frame: 4 weeks and 3 months after product use
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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.
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4 weeks and 3 months after product use
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Number of participants with changes to mucosal health
Time Frame: 4 weeks and 3 months after product use
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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.
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4 weeks and 3 months after product use
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with systemic inflammation
Time Frame: 4 weeks and 3 months after product use
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Evaluate changes from baseline in systemic factors associated with reproductive health, including C reactive protein and hormone concentrations.
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4 weeks and 3 months after product use
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mucosal susceptibility to pathogens
Time Frame: 4 weeks and 3 months after product use
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Model mucosal susceptibility to STIs ex vivo at baseline and after contraceptive use
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4 weeks and 3 months after product use
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Andrea Thurman, Eastern Virginia Medical School, CONRAD
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Gastrointestinal Diseases
- Gastroenteritis
- Stomatognathic Diseases
- Mouth Diseases
- Inflammation
- Mucositis
- Physiological Effects of Drugs
- Antineoplastic Agents
- Antineoplastic Agents, Hormonal
- Trace Elements
- Micronutrients
- Contraceptive Agents, Hormonal
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptives, Oral
- Contraceptive Agents, Female
- Contraceptives, Oral, Synthetic
- Contraceptives, Oral, Hormonal
- Contraceptive Agents, Male
- Copper
- Levonorgestrel
- Medroxyprogesterone Acetate
- Medroxyprogesterone
- Etonogestrel
Other Study ID Numbers
- CONRAD D20-149
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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