Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NIH-1
Study information
Scientific title
Acronym
MUSE
Study hypothesis
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
Ethics approval received from the Lothian Research Ethics Committee on the 11th February 2003 (ref: REC/2002/6/39).
Study design
Randomised, double blind, placebo controlled parallel group study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Breakthrough bleeding
Intervention
Administration of CDB-2914 for three consecutive days, for the first three months after LNG-IUS insertion.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Suppression of breakthrough bleeding in new users of LNG-IUS users.
2. Acceptability of breakthrough bleeding frequency.
Secondary outcome measures
Underlying mechanism of breakthrough bleeding.
Overall trial start date
01/01/2005
Overall trial end date
01/08/2007
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
150
Participant 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
Recruitment start date
01/01/2005
Recruitment end date
01/08/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
47 Little France Crescent
Edinburgh
EH16 4TJ
United Kingdom
Sponsor information
Organisation
National Institute of Child Health and Development (NICHD) (USA)
Sponsor details
National Institutes of Health
9000 Rockville Pike
Maryland
Bethesda
20892
United States of America
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
National Institutes of Health (USA) - US National Institute of Child Health and Development (NICHD-USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19897857
Publication citations
-
Results
Warner P, Guttinger A, Glasier AF, Lee RJ, Nickerson S, Brenner RM, Critchley HO, Randomized placebo-controlled trial of CDB-2914 in new users of a levonorgestrel-releasing intrauterine system shows only short-lived amelioration of unscheduled bleeding., Hum. Reprod., 2010, 25, 2, 345-353, doi: 10.1093/humrep/dep377.