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

ISRCTN	ISRCTN58283041
DOI	https://doi.org/10.1186/ISRCTN58283041
Protocol serial number	NIH-1
Sponsor	National Institute of Child Health and Development (NICHD) (USA)
Funder	National Institutes of Health (USA) - US National Institute of Child Health and Development (NICHD-USA)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Hilary Critchley
Scientific

47 Little France Crescent
Edinburgh
EH16 4TJ
United Kingdom

Primary study design	Interventional
Study design	Randomised, double blind, placebo controlled parallel group study
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	MUSE
Study objectives	1. Acceptibility study: development of questionnaire to assess acceptability of bleeding frequency and impact of proposing treatment in breakthrough bleeding. 2. Evaluate intervention strategy for suppression of breakthrough bleeding.
Ethics approval(s)	Ethics approval received from the Lothian Research Ethics Committee on the 11th February 2003 (ref: REC/2002/6/39).
Health condition(s) or problem(s) studied	Breakthrough bleeding
Intervention	Administration of CDB-2914 for three consecutive days, for the first three months after LNG-IUS insertion.
Intervention type	Other
Primary outcome measure(s)	1. Suppression of breakthrough bleeding in new users of LNG-IUS users. 2. Acceptability of breakthrough bleeding frequency.
Key secondary outcome measure(s)	Underlying mechanism of breakthrough bleeding.
Completion date	01/08/2007

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	150
Key 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
Key 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
Date of first enrolment	01/01/2005
Date of final enrolment	01/08/2007

47 Little France Crescent

Edinburgh
EH16 4TJ
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2010		Yes	No