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

ISRCTN ISRCTN58283041
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

47 Little France Crescent
Edinburgh
EH16 4TJ
United Kingdom

Study information

Study designRandomised, double blind, placebo controlled parallel group study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study acronymMUSE
Study objectives1. 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) studiedBreakthrough bleeding
InterventionAdministration of CDB-2914 for three consecutive days, for the first three months after LNG-IUS insertion.
Intervention typeOther
Primary outcome measure1. Suppression of breakthrough bleeding in new users of LNG-IUS users.
2. Acceptability of breakthrough bleeding frequency.
Secondary outcome measuresUnderlying mechanism of breakthrough bleeding.
Overall study start date01/01/2005
Completion date01/08/2007

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants150
Key inclusion criteria1. 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 criteria1. 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 enrolment01/01/2005
Date of final enrolment01/08/2007

Locations

Countries of recruitment

  • Scotland
  • United Kingdom

Study participating centre

47 Little France Crescent
Edinburgh
EH16 4TJ
United Kingdom

Sponsor information

National Institute of Child Health and Development (NICHD) (USA)
Government

National Institutes of Health
9000 Rockville Pike
Maryland
Bethesda
20892
United States of America

Website http://www.nih.gov
ROR logo "ROR" 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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