Suppression of breakthrough bleeding in levonorgestrel intrauterine system (Mirena system) users

Completed

• Conditions: Breakthrough bleeding; Urological and Genital Diseases; Abnormal vaginal bleeding

• Registration Number: ISRCTN58283041
• Lead Sponsor: ational Institute of Child Health and Development (NICHD) (USA)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12-28
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

1. Healthy female volunteers aged between 19 to 48 years
2. Requesting and receiving a LevoNorGestrel IntraUterine System (LNG-IUS) for contraception
3. Must have menstrual cycle of 17 to 42 days, lasting not longer than ten days
4. Not currently using any form of hormonal treatment

Exclusion Criteria

1. Is less than three months postpartum
2. Is less than one month post-lactation
3. Has been sterilised
4. Abnormal laboratory test finding clinically significant at screening or insertion
5. Currently participating in another study
6. History of cancer in the five years previously
7. History of significant medical disease
8. History of significant psychatric illness
9. Is currently on corticosteroid therapy
10. Unwilling or unsuitable for assessment and follow up
11. History of drug/alcohol abuse in past year
12. Found to have significant gynaecological disorder
13. History of abnormal vaginal bleeding
14. Has coagulopathy or on anticoagulation
15. Allergy to ingredients

Study & Design

• Study Type: Interventional
• Study Design: Not specified