Clinical trial NCT00967746: An Explorative Trial to Explore the Safety, Acceptability and Vaginal Bleeding Pattern of Three Etonogestrel-releasing Medicated Intrauterine Systems (Study P06060)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Contraception
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2009-08-28
Enrollment: 84
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a phase 2, randomized, active-controlled, parallel-group, multicenter, single-blind trial of three different doses of etonogestrel releasing medicated intrauterine systems (ENG-MIUS) in healthy parous women in need for contraception.

The primary trial objective is to explore safety and acceptability of three doses of an ENG-releasing medicated intrauterine system (ENG-MIUS) as compared to Multiload-cu 375®.


Eligibility criteria: Inclusion Criteria:

* Healthy female subjects in need for contraception will be selected to participate in the trial;
* Each subject must be \>=18 to \<=40 years of age at screening and in need for contraception;
* Each subject must have given birth to at least one child (gestational age \>=28 weeks);
* 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.

Exclusion Criteria:

* A subject must not be pregnant or suspected to be pregnant;
* 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;
* A subject must not have a history or presence of any malignancy;
* A subject must not have a history or presence of premalignant disease of the uterus or cervix, including endometrial hyperplasia, or (other) sex-steroid sensitive premalignancies;
* A subject must not have an active venous thromboembolic disorder (e.g. deep vein thrombosis, pulmonary embolism);
* A subject must not have a history or presence of severe hepatic disease with AST and/or ALT levels of \>=3 times the upper normal limit;
* A subject must not have congenital or acquired malformations or distortions of the uterus or cervix;
* 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;
* A subject must not have vaginal bleeding of undiagnosed etiology;
* A subject must not have dysmenorrhea interfering with daily activities or menorrhagia

Primary outcomes:
measure: The primary efficacy outcome for the trial is insertion and removal characteristics, adverse event reporting and subject's satisfaction with the ENG-MIUS
timeFrame: 6 months
Secondary outcomes:
measure: Vaginal bleeding pattern
timeFrame: Days 92 to 182
Other outcomes:
Locations:
Study officials:
References: