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

Completed

• Conditions: draagcomfort en insertie/verwijdering van IUS; insertion/removal; wearing comfort

• Registration Number: NL-OMON32633
• Lead Sponsor: Bayer

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 40

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 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Pelvic pain during the IUS wearing period (wearing comfort) measured by 5-point<br /><br>Likert scale (no pain/mild/moderate/severe/very severe pain).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Need of painkillers due to pelvic pain during the wearing period<br /><br>- Insertion/removal easiness evaluated by the physician<br /><br>- Insertion/removal pain evaluated by the volunteer<br /><br>- Need of pain relief during or after insertion<br /><br>- Need of dilatation of the cervix<br /><br>- Overall assessment of preference for insertion technique by the physician<br /><br>- Frequency of expulsions<br /><br>- Evaluation of menstrual bleedings<br /><br>- Safety parameters: Basic lab (e.g. blood count, pregnancy test),- Pap smear,<br /><br>Chlamydia/Gonorrhea, Ultrasound</p><br>