Effectiveness and Cost-effectiveness of Levonorgestrel containing Intrauterine system in Primary care against Standard treatment for menorrhagia

ISRCTN	ISRCTN86566246
DOI	https://doi.org/10.1186/ISRCTN86566246
Secondary identifying numbers	HTA 02/06/02

Submission date: 10/06/2004
Registration date: 11/06/2004
Last edited: 06/11/2023

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

Not provided at time of registration

Study website

Contact information

Prof Janesh Gupta
Scientific

Academic Department of Obstetrics and Gynaecology
Birmingham Women's Hospital
Metchley Park Road
Edgbaston
Birmingham
B15 2TG
United Kingdom

Phone	+44 (0)121 607 4751
Email	j.k.gupta@bham.ac.uk

Study information

Study design	Randomized controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	GP practice
Study type	Treatment
Participant information sheet	Patient information can be found at: http://www.eclipse.bham.ac.uk/documents/Eclipse_PIS_v1.1_dated_21.07.08.pdf
Scientific title	Effectiveness and Cost-effectiveness of Levonorgestrel containing Intrauterine system in Primary care against Standard treatment for menorrhagia: a randomised controlled trial
Study 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.
Ethics approval(s)	South West Research Ethics Committee, 18/08/2004, ref: 04/MRE06/7. The latest approval for amendments was given on 25/07/2008.
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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Levonorgestrel
Primary outcome measure	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 study start date	01/11/2004
Overall study end date	31/12/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	25 Years
Upper age limit	50 Years
Sex	Female
Target number of participants	570
Total final enrolment	571
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 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

England
United Kingdom

Study participating centre

Birmingham Women's Hospital

Birmingham
B15 2TG
United Kingdom

Sponsor information

University of Birmingham (UK)
University/education

Edgbaston
Birmingham
B15 2TT
England
United Kingdom

Website	http://www.bham.ac.uk/
"ROR"	https://ror.org/03angcq70

Funders

Funder type

Government

Health Technology Assessment Programme
Government organisation / National government

Alternative name(s): NIHR Health Technology Assessment Programme, HTA
Location: United Kingdom

Results and Publications

Intention to publish date
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	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	10/01/2013		Yes	No
Results article	results	01/10/2015		Yes	No
Results article		14/11/2022	15/11/2022	Yes	No
Other publications	10-year observational follow-up study	01/10/2023	06/11/2023	Yes	No

Editorial Notes

06/11/2023: Publication reference added.
15/11/2022: Publication reference and total final enrolment added.
17/01/2008: the overall trial start and end dates were updated from 01/01/2004 and 31/08/2012 to 01/11/2004 and 30/06/2013, respectively.
30/01/2009: extensive amendments were made to this 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.
04/09/2009: the overall trial end date was updated from 30/06/2013 to 31/12/2014.