Suppression of breakthrough bleeding in levonorgestrel intrauterine system (Mirena system) users
ISRCTN | ISRCTN58283041 |
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DOI | https://doi.org/10.1186/ISRCTN58283041 |
Secondary identifying numbers | NIH-1 |
- Submission date
- 08/11/2006
- Registration date
- 28/12/2006
- Last edited
- 16/11/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Hilary Critchley
Scientific
Scientific
47 Little France Crescent
Edinburgh
EH16 4TJ
United Kingdom
Study information
Study design | Randomised, double blind, placebo controlled parallel group study |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
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 | 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 study start date | 01/01/2005 |
Completion date | 01/08/2007 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Female |
Target number of participants | 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 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
47 Little France Crescent
Edinburgh
EH16 4TJ
United Kingdom
EH16 4TJ
United Kingdom
Sponsor information
National Institute of Child Health and Development (NICHD) (USA)
Government
Government
National Institutes of Health
9000 Rockville Pike
Maryland
Bethesda
20892
United States of America
Website | http://www.nih.gov |
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https://ror.org/04byxyr05 |
Funders
Funder type
Government
National Institutes of Health (USA) - US National Institute of Child Health and Development (NICHD-USA)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | results | 01/02/2010 | Yes | No |