To explore saftey and acceptability of three doses of an etonogestrel-releasing medicated intrauterine system (ENG-MIUS) as compared to Multiload-cu 375®.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
contraceptie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Safety and acceptability
Secondary outcome
Vaginal bleeding pattern
Ovarian function
Cervical mucus and endometrial thickness
Contraceptive efficacy
For subgroup:
ENG serum pharmacokinetics
Background summary
For the currecnt trial, a new medicated intrauterine system (MIUS) was
developed by incorporating a hormone-releasing fiber in an IUD. The chosen
'frame and fiber' MIUS concept allows for a variety of active ingredients to be
incorporated in the system. Apart from adding to the contraceptive effect of
the device and improving the vaginal bleeding pattern, the (local) addition of
hormone may be effective in treating a vaiety of women's health indications
such as endomterioses and dysmenorrhea.
Study objective
To explore saftey and acceptability of three doses of an etonogestrel-releasing
medicated intrauterine system (ENG-MIUS) as compared to Multiload-cu 375®.
Study design
A randomized, active-controlled, parallel-group, multicenter, single-blind
trial of three ENG-MIUSs in healthy parous women in need for contracpetion.
Intervention
Etonogestrel-releasing medicated intrauterine system (ENG-MIUS) three doses
or
copper-releasing intrauterine device (IUD)
Study burden and risks
At screening and after end of treatment/ prem. disc: physical/ gynaecological
examination, transvaginal ultrasound, cervical smear, bloodsampling,
endomterial biopsy.
At randomisation the MIUS/ IUD is inserted and removed at end of treatment.
From randomisation till month 6 (and at extension month 12)/ prem. disc.: fill
in daily diary with regards to daily menstrual bleeding; sexual intercourse and
condom use (monthly).
Visit 3, 4, 5 (day7 and end of month 1 and 3): transvaginal ultrasound and only
at visit 5 bloddsampling.
In the months subject doesn't visit the site a home pregnancy test has to be
performed.
At the subgroep additional at visit 3 till visit 8 (day 3 and then each fourth
day till day 23) and visit 11 till visit 17 (first day of Month 6 and then each
fourth day untill day 23 in Month 6): transvaginal ultrasounds and
bloodsampling. Biopsy at visit 6 and 15.
Walmolen 1
3994 DL Houten
NL
Walmolen 1
3994 DL Houten
NL
Listed location countries
Age
Inclusion criteria
Healthy female subjects in need for contraception.
Age at least 18-40 years at screening.
Subjects must have given birth to at least one child (gestational age >= 28 weeks).
Exclusion criteria
Exclusion criteria are mainly base on the approved labeling for Multiload® and Implanon®. ;• an ectopic pregnancy in the past or must not have a history or presence of predisposing factors for this condition such as salpingitis, endometritis or pelvic peritonitis
• a sex-steroid sensitive malignancy
• active venous thromboembolic disorder
• severe hepatic disease in the past
• premalignant disease of the uterus or cervix, a.o. lsrge or multiple uterine fibromyomata
• vaginal bleeding of undiagnosed etiology severe, dysmenorrhea or menorrhagia
• an abnormal cervical smear
• a genital infection
• active pelvic inflammatory disease (PID) at screening or must not have a history of recurrent PID (defined as twice a year)
• chlamydia, gonorrhea, or human immunodeficiency virus (HIV) at screening or within 12 months prior to screening
• a history of complete or partial expulsion with another IUD/IUS in the history
• an infected abortion within three months prior to screening, an abortion or delivery within six weeks or a caesarean section within three months prior to screening, incomplete uterine involution after abortion or postpartum
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 |
|---|---|
| EudraCT | EUCTR2009-012121-11-NL |
| CCMO | NL29449.056.09 |