An Explorative Trial to Explore the Safety, Acceptability and Vaginal Bleeding Pattern of Three Etonogestrel-releasing Medicated Intrauterine Systems (Study P06060)

Condition(s) targeted: Contraception

Intervention: Etonogestrel-releasing IUS (Drug); Etonogestrel-releasing IUS (Drug); Etonogestrel-releasing IUS (Drug); Multiload-cu 375® (Device)

Phase: Phase 2

Status: Not yet recruiting

Sponsored by: Schering-Plough

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®.

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 design: Prevention, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety Study

Primary outcome: The primary efficacy outcome for the trial is insertion and removal characteristics, adverse event reporting and subject's satisfaction with the ENG-MIUS

Secondary outcome: Vaginal bleeding pattern

Minimum age: 18 Years. Maximum age: 40 Years. Gender(s): Female.

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

Starting date: October 2009
Ending date: August 2011
Last updated: October 2, 2009