Impact of Contraceptives on Cervico-Vaginal Mucosa

Last updated: August 24, 2023
Sponsor: Eastern Virginia Medical School
Overall Status: Completed

Phase

4

Condition

Inflammation

Ulcerative Colitis (Pediatric)

Mucositis

Treatment

Copper IUD

DMPA Sub-cutaneous

Levonorgestrel IUS

Clinical Study ID

NCT04814927
CONRAD D20-149
  • Ages 18-50
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 18 to 50 years, inclusive
  • In general good health without any significant systemic disease and with an intactuterus and cervix.
  • History of Pap smears and follow-up consistent with standard, local clinical practiceor 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 acceptingrandomization to study contraceptive products
  • If currently on a contraceptive product, willing to go off products and use condomsfor birth control for a specified time
  • If in a relationship, must be with a partner who is not known to be HIV positive andhas no know risk of sexually transmitted infections (STIs)

Exclusion

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 thecourse 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 contraceptiveproduct to which a participant could receive at the clinical site
  • History of sensitivity/allergy to any component of the study product, topicalanesthetic, or to both silver nitrate and Monsel's solution
  • Current infection with Trichomonas vaginalis (TV), Neisseria gonorrhea (NG), Chlamydiatrachomatis (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 orcontinuous bleeding with biopsy
  • Chronic use systemic corticosteroids, antibiotics, antimycobacterials, anticoagulantsor other drugs known to prolong bleeding and/or promote clotting, antifungals, orantivirals 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 thelast 30 days or planned participation in any other investigational trial with use of adrug/device during the study
  • Abnormal finding on laboratory or physical examination or a social or medicalcondition in which, in the opinion of the investigator, would make participation inthe study unsafe or would complicate interpretation of the data

Study Design

Total Participants: 112
Treatment Group(s): 4
Primary Treatment: Copper IUD
Phase: 4
Study Start date:
March 01, 2021
Estimated Completion Date:
December 15, 2022

Study 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.

Connect with a study center

  • KEMRI

    Thika, Central 01000
    Kenya

    Site Not Available

  • Eastern Virginia Medical School

    Norfolk, Virginia 23507
    United States

    Site Not Available

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