Condition category
Urological and Genital Diseases
Date applied
08/11/2006
Date assigned
28/12/2006
Last edited
16/11/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Hilary Critchley

ORCID ID

Contact details

47 Little France Crescent
Edinburgh
EH16 4TJ
United Kingdom

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

http://www.nih.gov

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

  1. 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.

Additional files

Editorial Notes