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

Sponsor:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00967746

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: SCH 900342 ORG 299001
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: SCH 900342 ORG 299001
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: SCH 900342 ORG 299001
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 May 23, 2012