FR01 and FR20 IUS (Intrauterine System) Wearing Study
Phase 1
Completed
- Conditions
- Contraception
- Registration Number
- NCT01595022
- Lead Sponsor
- Bayer
- Brief Summary
The aim of the study is to evaluate two different placebo intrauterine systems, placebo FR01 and FR20 with different types of inserters, for wearing comfort, insertion/removal ease and pain compared to a placebo T-frame intrauterine system.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 90
Inclusion Criteria
- Healthy Female subject
- Age 18-40 years (inclusive)
- History of regular cyclic menstrual periods at baseline (cycle length 21 to 35 days)
- Women using any COC (combined oral contraceptive) for contraception with a monthly regimen before the study entry.
- Confirmed uterine sound depth of 6 to 10 cm
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Exclusion Criteria
- Pregnancy or lactation
- Sterilized
- Nulliparous
- Congenital or acquired uterine anomaly
- Vaginal or cesarean delivery within 8 weeks prior to insertion
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Pelvic pain during the IUS wearing period (wearing comfort) measured by 5-point Likert scale (no pain/mild/moderate/severe/very severe pain) 3 months
- Secondary Outcome Measures
Name Time Method