An Explorative Trial to Explore the Safety, Acceptability and Vaginal Bleeding Pattern of Three Etonogestrel-releasing Medicated Intrauterine Systems (Study P06060)(COMPLETED)
This study has been completed.
Sponsor:
Schering-Plough
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00967746
First received: August 27, 2009
Last updated: August 26, 2011
Last verified: August 2011
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Contraception |
Drug: Etonogestrel-releasing IUS Device: Multiload-cu 375® |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention |
| 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) |
Resource links provided by NLM:
MedlinePlus related topics:
Birth Control
Drug Information available for:
Etonogestrel
U.S. FDA Resources
Further study details as provided by Schering-Plough:
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 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Vaginal bleeding pattern [ Time Frame: Days 92 to 182 ] [ Designated as safety issue: No ]
| Enrollment: | 84 |
| Study Start Date: | November 2009 |
| Study Completion Date: | July 2011 |
| Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp |
| ClinicalTrials.gov Identifier: | NCT00967746 History of Changes |
| Other Study ID Numbers: | P06060 |
| Study First Received: | August 27, 2009 |
| Last Updated: | August 26, 2011 |
| Health Authority: | European Union: European Medicines Agency |
Additional relevant MeSH terms:
|
Hemorrhage Uterine Hemorrhage Pathologic Processes Uterine Diseases Genital Diseases, Female 3-keto-desogestrel Desogestrel Contraceptive Agents, Female Contraceptive Agents |
Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Progestins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Contraceptives, Oral, Synthetic Contraceptives, Oral |
ClinicalTrials.gov processed this record on June 17, 2013