Condition category
Nutritional, Metabolic, Endocrine
Date applied
15/01/2009
Date assigned
26/01/2009
Last edited
11/05/2010
Prospective/Retrospective
Prospectively 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 Janice Rymer

ORCID ID

Contact details

Department of Women's Health
Tenth Floor North Wing
St Thomas' Hospital
London
SE1 7EH
United Kingdom

Additional identifiers

EudraCT number

2008-002599-86

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A prospective open randomised controlled trial of women diagnosed with premature ovarian failure (POF) to investigate the effects of active treatment with hormone replacement therapy (HRT) or combined oral contraceptive pill (COCP), and observation of patients who choose to have no treatment, on bone density, markers of cardiovascular disease, markers of bone metabolism, menopausal symptoms, quality of life, depression score, sexual function and ovarian function over two years

Acronym

Study hypothesis

It is assumed that bone loss will occur at the normal post-menopausal rate in the no treatment group and that bone mass will be preserved and will be equal in the two treatment groups (hormone replacement therapy [HRT] and combined oral contraceptive pill [COCP]).

Ethics approval

Guy's Research Ethics Committee, approved on 18/12/2008 (ref: 08/H0804/140)

Study design

Prospective open randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Premature ovarian failure

Intervention

Participants will be asked whether they wish to receive treatment or prefer not to receive treatment. Those who choose to be in the active treatment group will be randomised to take either Nuvelle® or Microgynon® 30 for two years. Nuvelle® is oestradiol 2 mg once a day for 16 days then oestradiol 2 mg and levonorgestrel 75 mcg for 16 days on a cyclical basis. Microgynon® 30 is ethinylestradiol 30 mcg and levonorgestrel 150 mcg daily for 21 days followed by a 7 day pill-free break on a cyclical basis.

The participants who decide not to receive treatment will be followed-up for two years.

Intervention type

Drug

Phase

Not Applicable

Drug names

Nuvelle®, Microgynon®

Primary outcome measures

Bone mineral density at the lumbar spine and hip, assessed at 0, 6, 12 and 24 months.

Secondary outcome measures

1. Serum markers of bone metabolism, assessed at 0, 6, 12 and 24 months
2. Menopausal symptom scores, assessed at 0, 3, 6, 12, 18, 24 months
3. Depression score, assessed at 0, 3, 6, 12, 18, 24 months
4. Sexual function, assessed at 0, 3, 6, 12, 18, 24 months
5. Quality of life, assessed by SF-36® Health Survey at 0, 3, 6, 12, 18, 24 months
6. Serum markers of cardiovascular disease (lipid profile, C reactive protein [CRP]), assessed at 0, 6, 12 and 24 months
7. Ovarian function markers (anti-Mullerian hormone [AMH] and inhibin-B), assessed at 0, 6, 12, 24 months
8. Ovarian volume and antral follicle count, assessed by ultrasound at 0, 6, 12, 24 months

Overall trial start date

01/03/2009

Overall trial end date

01/09/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age 18-44 years
2. Women with a diagnosis of premature ovarian failure (POF) within the last 36 months (with documented follicle-stimulating hormone [FSH] level >30 IU on 2 occasions 4-8 weeks apart)
3. Ability to understand English
4. Written informed consent for participation in the trial
5. Not taking hormone medication (HRT/COCP/"natural" preparations) for 2 months prior to commencement in the trial

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

66

Participant exclusion criteria

1. Age less than 18 or over 45 years
2. Current desire for pregnancy is an exclusion criterion from the active treatment group (as she may be randomised to take COCP). However, she could elect to take part in the no treatment group.
3. Women with absolute contraindications to hormone treatment will be excluded from the active treatment group (i.e. personal history of thromboembolic disease, oestrogen dependent malignancies, and personal history of focal migraine)
4. Women taking medication for high cholesterol or found to have raised cholesterol levels on initial assessment
5. Untreated thyroid disease

Recruitment start date

01/03/2009

Recruitment end date

01/09/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Women's Health
London
SE1 7EH
United Kingdom

Sponsor information

Organisation

King's College London (UK)

Sponsor details

c/o Jackie Pullen
Third Floor Conybeare House
Great Maze Pond
London
SE1 9RT
United Kingdom

Sponsor type

University/education

Website

http://www.kcl.ac.uk/

Funders

Funder type

Charity

Funder name

Wellcome Trust (UK), Research Training Fellowship, decision expected in April 2009 (ref: 10092)

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

2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/20424282

Publication citations

  1. Protocol

    Cartwright B, Robinson J, Rymer J, Treatment of premature ovarian failure trial: description of an ongoing clinical trial., Menopause Int, 2010, 16, 1, 18-22, doi: 10.1258/mi.2010.010010.

Additional files

Editorial Notes