To evaluate two different placebo intrauterine systems, pentagon-shaped placebo FR01 and traingle-shaped FR20 with different types of inserters, for wearing comfort, insertion/removal ease and pain compared to a placebo T-frame intrauterine system.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
draagcomfort en insertie/verwijdering van IUS
Research involving
Sponsors and support
Intervention
Outcome measures
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).
Secondary outcome
- 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
Background summary
Aim of the study is to develop a levonorgestrel (LNG) releasing IUS for
contraception for 3 years
with a simplified/easier insertion procedure, high wearing comfort for users,
low risk of
perforation.
The concept consists of a new continuous frame with a LNG containing drug
reservoir of the same core material as in
Mirena®, the LNG releasing IUS available on the global market since about 20
years. Placebo drug reservoirs,
round-shaped with concept FR01 and flat-shaped with concept FR20, will be used
in the
planned first human study and will be compared with T-shaped IUS which is a
smaller version of the earlier mentioned Mirena®.
Both concepts will be further developed for later phased clinical studies with
an active drug
releasing reservoir. There is, therefore, no need to show superiority between
the products at
this stage of the product development.
Study objective
To evaluate two different placebo intrauterine systems, pentagon-shaped placebo
FR01 and traingle-shaped FR20 with different types of inserters, for wearing
comfort, insertion/removal ease and pain compared to a placebo T-frame
intrauterine system.
Study design
Randomized, multicenter, single blinded, controlled, parallel group study
No active drug substance
Treatment duration: 3 months
Study sites from 2-3 countries, 10 sites
Totally around 90, minimum 30/group
Intervention
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 intrauterine system
Study burden and risks
Discomfort during insertion
Accidental pregnancy (the IUS have no contraceptive efficacy, therefore COC is
prescribed).
Expulsion of the intrauterine system is possible.
Uterine perforation occurs in 1 out of 1000 insertions.
An IUS with no drug release may increase the amount of bleeding and frequency
of menustrual bleeding/spotting
Pelvic infection is possible in this study. Such infection is mainly associated
with behavioral factors such as multiplicity of sexual partners.
Other side effects might be lower abdominal pain, pelivic and back pain,
inflammation of the genitials and cervicitis, which is an infection, in the
opening of the womb.
Energieweg 1
3641 RT Mijdrecht
Nederland
Energieweg 1
3641 RT Mijdrecht
Nederland
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL30606.040.09 |