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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Organon

Status and phase

Completed
Phase 2

Conditions

Contraception

Treatments

Drug: Etonogestrel-releasing IUS
Device: Multiload-cu 375®

Study type

Interventional

Funder types

Industry

Identifiers

NCT00967746
P06060

Details and patient eligibility

About

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®.

Enrollment

84 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

84 participants in 4 patient groups

ENG-MIUS low
Experimental group
Description:
Low dose: ENG-MIUS containing 38 mg ENG with a skin thickness of approximately 350 μm
Treatment:
Drug: Etonogestrel-releasing IUS
ENG-MIUS intermediate
Experimental group
Description:
Intermediate dose: ENG-MIUS containing 61 mg ENG with a skin thickness of approximately 140 μm
Treatment:
Drug: Etonogestrel-releasing IUS
ENG-MIUS high
Experimental group
Description:
High dose: ENG-MIUS containing 72 mg ENG with a skin thickness of approximately 50 μm
Treatment:
Drug: Etonogestrel-releasing IUS
Multiload
Active Comparator group
Description:
Multiload-cu 375®
Treatment:
Device: Multiload-cu 375®

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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