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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00967746
First received: August 27, 2009
Last updated: September 10, 2014
Last verified: September 2014
  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:


Further study details as provided by Merck Sharp & Dohme Corp.:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00967746     History of Changes
Other Study ID Numbers: P06060
Study First Received: August 27, 2009
Last Updated: September 10, 2014
Health Authority: European Union: European Medicines Agency

Additional relevant MeSH terms:
3-keto-desogestrel
Desogestrel
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on September 16, 2014