A randomized, multicenter, explorative trial to explore the safety, acceptability and vaginal bleeding pattern of three doses of an etonogestrel-releasing medicated intrauterine system (ENG-MIUS) versus a copper-releasing intrauterine device (IUD) (Phase 2; Protocol No. P06060 (299001))
- Conditions
- healthy parous women in need of contraceptionMedDRA version: 12.0Level: LLTClassification code 10010808Term: Contraception
- Registration Number
- EUCTR2009-012121-11-NL
- Lead Sponsor
- Schering-Plough Research Institute, a Division of Schering Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 80
1. Each subject must be 18 up to and including 40 years of age at screening and in need of contraception;
2. Each subject must have given birth to at least one child (gestational age = 28 weeks);
3. Each subject must have a uterus with a measured length between 6.0 and 9.0 cm (extremes included) from external os to fundus uteri.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. A subject must not be pregnant or suspected to be pregnant;
2. A subject must not have had 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;
3. A subject must not have any malignancy at screening and must not have a history of a sex-steroid sensitive malignancy eg, of the genital organs or the breast;
4. A subject must not have a premalignant disease of the uterus or cervix, including endometrial hyperplasia and cervical dysplasia, or (other) sex-steroid sensitive premalignancies;
5. A subject must not have an active venous thromboembolic disorder (eg, deep vein thrombosis, pulmonary embolism);
6. A subject must not have a history or presence of severe hepatic disease with aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) levels of = three times the upper normal limit;
7. A subject must not have congenital or acquired malformations or distortions of the uterus or cervix;
8. A subject must not have large or multiple uterine fibromyomata, or a smaller uterine fibromyoma which may interfere with the insertion of the MIUS/IUD according to the investigator;
9. A subject must not have vaginal bleeding of undiagnosed etiology;
10. A subject must not have dysmenorrhea interfering with daily activities or menorrhagia;
11. A subject must not have an abnormal cervical smear at screening, defined as Bethesda (2001) = low grade squamous intraepithelial lesion (LSIL) or cervical intraepithelial neoplasia (CIN) = CIN 1;
12. A subject must not have a genital infection at MIUS/IUD insertion;
13. A subject must not have active pelvic inflammatory disease (PID) at screening or must not have a history of recurrent PID (defined as twice a year);
14. A subject must not have chlamydia, gonorrhea, or human immunodeficiency virus (HIV) at screening or must not have had these diseases within 12 months prior to screening;
15. A subject must not have a history of complete or partial expulsion with another IUD/IUS;
16. A subject must not have had an infected abortion within three months prior to screening;
17. A subject must not have had an abortion or delivery within six weeks or a caesarean section within three months prior to screening, and must not have an incomplete uterine involution after abortion or postpartum.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To explore safety and acceptability of three doses of an etonogestrel-releasing medicated intrauterine system (ENG-MIUS) as compared to Multiload-cu 375® .;Secondary Objective: To explore the effect of three doses of ENG-MIUS as compared to Multiload-cu 375® on:<br>•Vaginal bleeding pattern;<br>•Ovarian function;<br>•Cervical mucus and endometrial thickness;<br>•Contraceptive efficacy.<br>To explore for three doses of ENG-MIUS:<br>•ENG serum pharmacokinetics;;Primary end point(s): Efficacy Analysis:<br>The Primary Efficacy Endpoint for the current trial is the vaginal bleeding pattern defined as the number of bleeding and/or spotting days in the second reference period of 91 days.<br>Safety Analysis:<br>The Descriptive Safety Endpoints related to the primary trial objective are insertion and removal characteristics, (serious) adverse event reporting, and subject’s satisfaction.<br>
- Secondary Outcome Measures
Name Time Method