healthy parous women in need of contraception MedDRA version: 12.0 Level: LLT Classification code 10010808 Term: Contraception
Conditions
Interventions
Product Name: Org 3236 MIUS 38 mg
Product Code: Org 3236 MIUS 38 mg
Pharmaceutical Form: Intrauterine delivery system
INN or Proposed INN: etonogestrel
CAS Number: 54048-10-1
Current Sponsor code: SCH
Sponsors
Schering-Plough Research Institute, a Division of Schering Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Each subject must be 18 up to and including 40 years of age at screening and in need of contraception; 2. Each subject must have given birth to at least one child (gestational age = 28 weeks); 3. 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. A subject must not be pregnant or suspected to be pregnant; 2. 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; 3. A subject must not have any malignancy at screening and must not have a history of a sex-steroid sensitive malignancy eg, of the genital organs or the breast; 4. A subject must not have a premalignant disease of the uterus or cervix, including endometrial hyperplasia and cervical dysplasia, or (other) sex-steroid sensitive premalignancies; 5. A subject must not have an active venous thromboembolic disorder (eg, deep vein thrombosis, pulmonary embolism); 6. A subject must not have a history or presence of severe hepatic disease with aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) levels of = three times the upper normal limit; 7. A subject must not have congenital or acquired malformations or distortions of the uterus or cervix; 8. 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; 9. A subject must not have vaginal bleeding of undiagnosed etiology; 10. A subject must not have dysmenorrhea interfering with daily activities or menorrhagia; 11. A subject must not have an abnormal cervical smear at screening, defined as Bethesda (2001) = low grade squamous intraepithelial lesion (LSIL) or cervical intraepithelial neoplasia (CIN) = CIN 1; 12. A subject must not have a genital infection at MIUS/IUD insertion; 13. A subject must not have active pelvic inflammatory disease (PID) at screening or must not have a history of recurrent PID (defined as twice a year); 14. A subject must not have chlamydia, gonorrhea, or human immunodeficiency virus (HIV) at screening or must not have had these diseases within 12 months prior to screening; 15. A subject must not have a history of complete or partial expulsion with another IUD/IUS; 16. A subject must not have had an infected abortion within three months prior to screening; 17. A subject must not have had an abortion or delivery within six weeks or a caesarean section within three months prior to screening, and must not have an incomplete uterine involution after abortion or postpartum.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To explore safety and acceptability of three doses of an etonogestrel-releasing medicated intrauterine system (ENG-MIUS) as compared to Multiload-cu 375® .;Secondary Objective: To explore the effect of three doses of ENG-MIUS as compared to Multiload-cu 375® on: • Vaginal bleeding pattern; • Ovarian function; • Cervical mucus and endometrial thickness; • Contraceptive efficacy. To explore for three doses of ENG-MIUS: • ENG serum pharmacokinetics;;Primary end point(s): Efficacy Analysis: The Primary Efficacy Endpoint for the current trial is the vaginal bleeding pattern defined as the number of bleeding and/or spotting days in the second reference period of 91 days. Safety Analysis: The Descriptive Safety Endpoints related to the primary trial objective are insertion and removal characteristics, (serious) adverse event reporting, and subject’s satisfaction. | — |
Countries
Germany, Netherlands
Outcome results
None listed