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

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 - FR01 and FR20 IUS wearing study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON32633

Enrollment

Registered

2010-01-08

Start date

2010-01-29

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

draagcomfort en insertie/verwijdering van IUS insertion/removal wearing comfort

Interventions

The subjects will be randomized in three arms. In each arm one of the following IUS systems will be evaluated: 1. pentagon-shaped placebo FR01 2. traingle-shaped placebo FR20 3. placebo T-frame intr

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: Pregnancy or lactation Sterilized Nulliparous Congenital or acquired uterine anomaly Vaginal or cesarean delivery within 8 weeks prior to insertion

Design outcomes

Primary

Measure	Time frame
Pelvic pain during the IUS wearing period (wearing comfort) measured by 5-point Likert scale (no pain/mild/moderate/severe/very severe pain).	—

Secondary

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

Measure

Time frame

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

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)