Back to resultsAn Explorative Trial to Explore the Safety, Acceptability and Vaginal Bleeding Pattern of Three Etonogestrel-releasing Medicated Intrauterine Systems (Study P06060)
Primary Purpose
Contraception
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Etonogestrel-releasing IUS
Etonogestrel-releasing IUS
Etonogestrel-releasing IUS
Multiload-cu 375®
Sponsored by
About this trial
This is an interventional prevention trial for Contraception
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Arm Label
ENG-MIUS low
ENG-MIUS intermediate
ENG-MIUS high
Multiload
Arm Description
Low dose: ENG-MIUS containing 38 mg ENG with a skin thickness of approximately 350 μm
Intermediate dose: ENG-MIUS containing 61 mg ENG with a skin thickness of approximately 140 μm
High dose: ENG-MIUS containing 72 mg ENG with a skin thickness of approximately 50 μm
Multiload-cu 375®
Outcomes
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
Secondary Outcome Measures
Vaginal bleeding pattern
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00967746
Brief Title
An Explorative Trial to Explore the Safety, Acceptability and Vaginal Bleeding Pattern of Three Etonogestrel-releasing Medicated Intrauterine Systems (Study P06060)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Organon and Co
4. Oversight
Data Monitoring Committee
No
5. 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®.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contraception
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ENG-MIUS low
Arm Type
Experimental
Arm Description
Low dose: ENG-MIUS containing 38 mg ENG with a skin thickness of approximately 350 μm
Arm Title
ENG-MIUS intermediate
Arm Type
Experimental
Arm Description
Intermediate dose: ENG-MIUS containing 61 mg ENG with a skin thickness of approximately 140 μm
Arm Title
ENG-MIUS high
Arm Type
Experimental
Arm Description
High dose: ENG-MIUS containing 72 mg ENG with a skin thickness of approximately 50 μm
Arm Title
Multiload
Arm Type
Active Comparator
Arm Description
Multiload-cu 375®
Intervention Type
Drug
Intervention Name(s)
Etonogestrel-releasing IUS
Other Intervention Name(s)
SCH 900342, ORG 299001
Intervention Description
Low dose; treatment duration of 6 months with a possible extension to 12 months
Intervention Type
Drug
Intervention Name(s)
Etonogestrel-releasing IUS
Other Intervention Name(s)
SCH 900342, ORG 299001
Intervention Description
Intermediate dose; treatment duration of 6 months with a possible extension to 12 months
Intervention Type
Drug
Intervention Name(s)
Etonogestrel-releasing IUS
Other Intervention Name(s)
SCH 900342, ORG 299001
Intervention Description
High dose; treatment duration of 6 months with a possible extension to 12 months
Intervention Type
Device
Intervention Name(s)
Multiload-cu 375®
Intervention Description
Duration of 6 months with a possible extension to 12 months
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Vaginal bleeding pattern
Time Frame
Days 92 to 182
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
12. IPD Sharing Statement
Learn more about this trial
An Explorative Trial to Explore the Safety, Acceptability and Vaginal Bleeding Pattern of Three Etonogestrel-releasing Medicated Intrauterine Systems (Study P06060)
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