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Impact of Contraceptives on Cervico-Vaginal Mucosa (UMPALA)

Primary Purpose

Mucosal Inflammation, Contraceptive; Complications, Intrauterine

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Copper IUD
Etonogestrel implant
Levonorgestrel IUS
DMPA Sub-cutaneous
Sponsored by
Eastern Virginia Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Mucosal Inflammation focused on measuring Contraception, Reproductive health, Copper IUD, Etonogestrel implant, DMPA sub-cutaneous, Levonorgestrel IUS

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Eastern Virginia Medical School
  • KEMRI

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Copper IUD

Etonogestrel Implant

Levonorgestrel IUS

DMPA Sub-cutaneous

Arm Description

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.

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.

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

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Number of participants with systemic inflammation
Evaluate changes from baseline in systemic factors associated with reproductive health, including C reactive protein and hormone concentrations.

Full Information

First Posted
March 18, 2021
Last Updated
August 24, 2023
Sponsor
Eastern Virginia Medical School
Collaborators
CONRAD, Kenya Medical Research Institute, United States Agency for International Development (USAID)
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1. Study Identification

Unique Protocol Identification Number
NCT04814927
Brief Title
Impact of Contraceptives on Cervico-Vaginal Mucosa
Acronym
UMPALA
Official Title
The UMPALA Study: A Clinical Study to Assess the Impact of Contraceptives on the Cervico-Vaginal Mucosa
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
December 15, 2022 (Actual)
Study Completion Date
December 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eastern Virginia Medical School
Collaborators
CONRAD, Kenya Medical Research Institute, United States Agency for International Development (USAID)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mucosal Inflammation, Contraceptive; Complications, Intrauterine
Keywords
Contraception, Reproductive health, Copper IUD, Etonogestrel implant, DMPA sub-cutaneous, Levonorgestrel IUS

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Participants at each site will receive one of four marketed, approved contraceptive products for the duration of the study.
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Copper IUD
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Etonogestrel Implant
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Levonorgestrel IUS
Arm Type
Active Comparator
Arm Description
The LNG IUS contains approximately 52 mg. of LNG. It is FDA approved for pregnancy prevention for 5 - 6 years.
Arm Title
DMPA Sub-cutaneous
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Copper IUD
Other Intervention Name(s)
Paragard
Intervention Description
Participants randomized to Copper IUD will receive Paragard IUD at Visit 2.
Intervention Type
Drug
Intervention Name(s)
Etonogestrel implant
Other Intervention Name(s)
Nexplanon, Implanon
Intervention Description
Participants randomized to ETG implant will receive the implant at Visit 2.
Intervention Type
Drug
Intervention Name(s)
Levonorgestrel IUS
Other Intervention Name(s)
Mirena, Liletta
Intervention Description
Participants randomized to LNG intrauterine system will receive the IUS at Visit 2.
Intervention Type
Drug
Intervention Name(s)
DMPA Sub-cutaneous
Other Intervention Name(s)
Subcutaneous depot medroxyprogesterone acetate
Intervention Description
Participants randomized to DMPA SC will receive the injection at Visit 2.
Primary Outcome Measure Information:
Title
Number of participants with changes to mucosal function
Description
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.
Time Frame
4 weeks and 3 months after product use
Title
Number of participants with changes to mucosal health
Description
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.
Time Frame
4 weeks and 3 months after product use
Secondary Outcome Measure Information:
Title
Number of participants with systemic inflammation
Description
Evaluate changes from baseline in systemic factors associated with reproductive health, including C reactive protein and hormone concentrations.
Time Frame
4 weeks and 3 months after product use
Other Pre-specified Outcome Measures:
Title
Mucosal susceptibility to pathogens
Description
Model mucosal susceptibility to STIs ex vivo at baseline and after contraceptive use
Time Frame
4 weeks and 3 months after product use

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Thurman
Organizational Affiliation
Eastern Virginia Medical School, CONRAD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eastern Virginia Medical School
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
KEMRI
City
Thika
State/Province
Central
ZIP/Postal Code
01000
Country
Kenya

12. IPD Sharing Statement

Plan to Share IPD
No

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Impact of Contraceptives on Cervico-Vaginal Mucosa

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