Trial Condition(s):
Contraception
FR01 and FR20 IUS (intrauterine system) wearing study
Bayer Identifier:
13830
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
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
Exclusion Criteria
- Pregnancy or lactation - Sterilized - Nulliparous - Congenital or acquired uterine anomaly - Vaginal or cesarean delivery within 8 weeks prior to insertion
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Atrium Medisch Centrum HEERLEN, Netherlands, 6401 CX | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Albert Schweitzer Ziekenhuis, locatie Zwijndrecht ZWIJNDRECHT, Netherlands, 3331 LZ | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Gemini Ziekenhuis Den Helder, Netherlands, 1780 AT | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Karolinska Universitetssjukhuset i Solna Stockholm, Sweden, 171 76 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Akademiska Sjukhuset Uppsala, Sweden, 75185 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitetssjukhuset Örebro, Sweden, 701 85 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Väestöliitto, Seksuaaliterveysklinikka, Helsinki Helsinki, Finland, 00100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Lääkäriasema Pulssi Turku, Finland, 20100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Suomen Terveystalo Tampere Tampere, Finland, 33100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Lääkäriasema Cantti Oy Kuopio, Finland, 70110 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
A multi-center, single-blinded, randomized, controlled, parallel-group study to evaluate the wearing comfort of two different placebo intrauterine systems FR01 and FR20 compared to a placebo T-frame intrauterine system for 3 cycles in healthy women aged 18-40 years
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Prevention
Allocation:
Randomized
Blinding:
Single Blind
Assignment:
Parallel Assignment
Trial Arms:
3
Primary Outcome
- Pelvic pain during the IUS wearing period (wearing comfort) measured by 5-point Likert scale (no pain/mild/moderate/severe/very severe pain)Timeframe: 3 months
Additional Information
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