An Explorative Trial to Explore the Safety, Acceptability and Vaginal Bleeding Pattern of Three Etonogestrel-releasing Medicated Intrauterine Systems (Study P06060)
Study Details
Study Description
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®.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: ENG-MIUS low Low dose: ENG-MIUS containing 38 mg ENG with a skin thickness of approximately 350 μm |
Drug: Etonogestrel-releasing IUS
Low dose; treatment duration of 6 months with a possible extension to 12 months
Other Names:
|
| Experimental: ENG-MIUS intermediate Intermediate dose: ENG-MIUS containing 61 mg ENG with a skin thickness of approximately 140 μm |
Drug: Etonogestrel-releasing IUS
Intermediate dose; treatment duration of 6 months with a possible extension to 12 months
Other Names:
|
| Experimental: ENG-MIUS high High dose: ENG-MIUS containing 72 mg ENG with a skin thickness of approximately 50 μm |
Drug: Etonogestrel-releasing IUS
High dose; treatment duration of 6 months with a possible extension to 12 months
Other Names:
|
| Active Comparator: Multiload Multiload-cu 375® |
Device: Multiload-cu 375®
Duration of 6 months with a possible extension to 12 months
|
Outcome Measures
Primary Outcome Measures
- 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
- Vaginal bleeding pattern [Days 92 to 182]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Healthy female subjects in need for contraception will be selected to participate in the trial;
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Each subject must be >=18 to <=40 years of age at screening and in need for contraception;
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Each subject must have given birth to at least one child (gestational age >=28 weeks);
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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;
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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;
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A subject must not have a history or presence of any malignancy;
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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;
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A subject must not have an active venous thromboembolic disorder (e.g. deep vein thrombosis, pulmonary embolism);
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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;
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A subject must not have congenital or acquired malformations or distortions of the uterus or cervix;
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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;
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A subject must not have vaginal bleeding of undiagnosed etiology;
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A subject must not have dysmenorrhea interfering with daily activities or menorrhagia
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Organon and Co
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- P06060