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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN87011615

Enrollment

Registered

2009-01-26

Start date

2009-03-01

Completion date

Unknown

Last updated

2018-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature ovarian failure Nutritional, Metabolic, Endocrine Ovarian dysfunction

Interventions

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

Eligibility

Sex/Gender

Female

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026