Last updated: January 19, 2023
Sponsor: CooperSurgical Inc.
Overall Status: Completed
Phase
4
Condition
Contraception
Treatment
N/AClinical Study ID
NCT05309694
CSIPD-001
Ages > 18 Female Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Subject is a postmenarcheal and premenopausal woman of child bearing potential.
- Subjects are at least 18 years of age, at the time of signing the informed consent.
- Subject is overtly healthy as determined by medical evaluation.
Exclusion
Exclusion Criteria:
- Pregnancy or suspicion of pregnancy or at risk for luteal phase pregnancy
- History of previous IUD complications
- Abnormalities of the uterus resulting in distortion of the uterine cavity that maycomplicate IUD insertion
- Known anatomical abnormalities of the cervix
- Presence of acute pelvic inflammatory disease at the time of screening.
- Postpartum endometritis.
- Known or suspected uterine or cervical malignancy.
- Uterine bleeding of unknown etiology.
- Untreated acute cervicitis or vaginitis or other lower genital tract infection.
- Conditions associated with increased susceptibility to pelvic infections.
- Subjects with Wilson's disease.
Study Design
Total Participants: 119
Study Start date:
March 04, 2022
Estimated Completion Date:
December 08, 2022
Study Description
Connect with a study center
Downtown Women's Healthcare
Denver, Colorado 80218
United StatesSite Not Available
South Miami Women's Health
South Miami, Florida 33143
United StatesSite Not Available
GYN-CARE Women's Healthcare
Atlanta, Georgia 30363
United StatesSite Not Available
Valley Ob-Gyn Clinic, PC
Saginaw, Michigan 48602
United StatesSite Not Available
Hilltop Obstetrics & Gynecology
Franklin, Ohio 45005
United StatesSite Not Available
Austin Area Ob-Gyn & Fertility
Austin, Texas 78758
United StatesSite Not Available
Central Austin - Women Partners in Health
Austin, Texas 78705
United StatesSite Not Available
Seattle Clinical Research Center
Seattle, Washington 98105
United StatesSite Not Available
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