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

Study Overview
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Brief Summary
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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
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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)

Conditions
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Contraception

Intervention / Treatment
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* Drug: Etonogestrel-releasing IUS
* Drug: Etonogestrel-releasing IUS
* Drug: Etonogestrel-releasing IUS
* Device: Multiload-cu 375®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ENG-MIUS low<br>Low dose: ENG-MIUS containing 38 mg ENG with a skin thickness of approximately 350 μm | Drug: Etonogestrel-releasing IUS<br>* Low dose; treatment duration of 6 months with a possible extension to 12 months<br>* Other names: ORG 299001;|
| Experimental: ENG-MIUS intermediate<br>Intermediate dose: ENG-MIUS containing 61 mg ENG with a skin thickness of approximately 140 μm | Drug: Etonogestrel-releasing IUS<br>* Intermediate dose; treatment duration of 6 months with a possible extension to 12 months<br>* Other names: ORG 299001;|
| Experimental: ENG-MIUS high<br>High dose: ENG-MIUS containing 72 mg ENG with a skin thickness of approximately 50 μm | Drug: Etonogestrel-releasing IUS<br>* High dose; treatment duration of 6 months with a possible extension to 12 months<br>* Other names: ORG 299001;|
| Active Comparator: Multiload<br>Multiload-cu 375® | Device: Multiload-cu 375®<br>* Duration of 6 months with a possible extension to 12 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary efficacy outcome for the trial is insertion and removal characteristics, adverse event reporting and subject's satisfaction with the ENG-MIUS |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaginal bleeding pattern |  | Days 92 to 182 |