Treatment of premature ovarian failure with hormone replacement therapy or combined oral contraceptive pill

Not Applicable

Completed

• Conditions: Premature ovarian failure; Nutritional, Metabolic, Endocrine; Ovarian dysfunction

• Registration Number: ISRCTN87011615
• Lead Sponsor: King's College London (UK)

Brief Summary

1. 2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/20424282 2. 2016 results in https://www.ncbi.nlm.nih.gov/pubmed/27340881

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-01-26
• Study Completion: 2011-09-01
• Last Update Posted: 10 September 2018

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 66

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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