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
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
Connect with a study center
KEMRI
Thika, Central 01000
KenyaSite Not Available
Eastern Virginia Medical School
Norfolk, Virginia 23507
United StatesSite Not Available
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