Condition category
Urological and Genital Diseases
Date applied
10/06/2004
Date assigned
11/06/2004
Last edited
11/01/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.eclipse.bham.ac.uk/

Contact information

Type

Scientific

Primary contact

Prof Janesh Gupta

ORCID ID

Contact details

Academic Department of Obstetrics and Gynaecology
Birmingham Women's Hospital
Metchley Park Road
Edgbaston
Birmingham
B15 2TG
United Kingdom
+44 (0)121 607 4751
j.k.gupta@bham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 02/06/02

Study information

Scientific title

Effectiveness and Cost-effectiveness of Levonorgestrel containing Intrauterine system in Primary care against Standard treatment for menorrhagia: a randomised controlled trial

Acronym

ECLIPSE

Study hypothesis

Menorrhagia is a very common problem affecting women’s lives. Attendant demand on time and resources in primary and secondary care is considerable. However it is unclear which treatment options are the most effective and the most acceptable to women, particularly in the long term, and experience of care varies widely. Currently 1 in 5 women in the UK have a hysterectomy, half of whom present with heavy periods. This trial will assess the effectiveness, cost effectiveness and acceptability of using the levonorgestrel IUS (Mirena coil) compared to standard medical treatment for women with menorrhagia presenting in primary care.

Please note that, as of 17/01/2008, the anticipated start and end dates of this trial have been updated from 01/01/2004 and 31/08/2012 to 01/11/2004 and 30/06/2013, respectively.

Please note that, as of 30/01/2009, extensive amendments have been made to this ISRCTN record, including the following:
1. Scientific title was added
2. Target number of participants was amended from 1,000 to 570
Other amendments are recorded within the relevant fields.

Please note that, as of 04/09/2009, the anticipated end date of this trail has been updated from 30/06/2013 to 31/12/2014.

Ethics approval

South West Research Ethics Committee, approved on 18/08/2004 (ref: 04/MRE06/7). The latest approval for amendments was given on 25/07/2008.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Patient information can be found at: http://www.eclipse.bham.ac.uk/documents/Eclipse_PIS_v1.1_dated_21.07.08.pdf

Condition

Menorrhagia

Intervention

Levonorgestrel-releasing intrauterine systems compared with standard medical treatment, based on the Royal College of Obstetricians and Gynaecologists (RCOG) guidelines

Intervention type

Drug

Phase

Not Applicable

Drug names

Levonorgestrel

Primary outcome measures

Added as of 30/01/2009:
The Shaw Menorrhagia Questionnaire

All primary and secondary outcomes will be assessed at baseline, 6 months, 1, 2 and 5 years with a possibility of 10 years.

Secondary outcome measures

Added as of 30/01/2009:
1. SF-36® Health Survey
2. Sexual Activity Questionnaire
3. Euroqol EQ-5D

All primary and secondary outcomes will be assessed at baseline, 6 months, 1, 2 and 5 years with a possibility of 10 years.

Overall trial start date

01/11/2004

Overall trial end date

31/12/2014

Reason abandoned

Eligibility

Participant inclusion criteria

Women between the ages of 25-50 presenting to General Practitioners with menorrhagia, who are not intending to become pregnant in the next 5 years

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

570

Participant exclusion criteria

1. Taking HRT
2. Patients with any contraindications to an IUS, with or without Levonorgestrel
3. Patients with contraindications to medical therapy
4. Women with abdominally palpable enlarged fibroid uteri (10-12 Weeks size)
5. Women to whom the contraceptive effect of LNG-IUS would be unacceptable.
6. Women with symptoms suggestive of other pathology (irregular bleeding, intermenstrual bleeding, postcoital bleeding)
7. Women with risk factors for endometrial cancer (tamoxifen treatment, unopposed ostrogen treatments)

Recruitment start date

01/11/2004

Recruitment end date

31/12/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Academic Department of Obstetrics and Gynaecology
Birmingham
B15 2TG
United Kingdom

Sponsor information

Organisation

University of Birmingham (UK)

Sponsor details

Edgbaston
Birmingham
B15 2TT
United Kingdom

Sponsor type

University/education

Website

http://www.bham.ac.uk/

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK)

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

1. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23301731

Publication citations

  1. Results

    Gupta J, Kai J, Middleton L, Pattison H, Gray R, Daniels J, , Levonorgestrel intrauterine system versus medical therapy for menorrhagia., N. Engl. J. Med., 2013, 368, 2, 128-137, doi: 10.1056/NEJMoa1204724.

Additional files

Editorial Notes