A prospective open randomised controlled trial of women diagnosed with premature ovarian failure (POF) to investigate the effects of active treatment with HRT (hormone replacement therapy) or COCP (combined oral contraceptive pill), 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 2 years. - Treatment of Premature Ovarian Failure
- Conditions
- Premature ovarian failureMedDRA version: 9.1Level: LLTClassification code 10036602Term: Premature ovarian failure
- Registration Number
- EUCTR2008-002599-86-GB
- Lead Sponsor
- Guy's and St Thomas Foundation NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 66
Age 18-45 years
Women with a diagnosis of POF within the last 36 months (with documented FSH level >30IU on 2 occassions 4-8 weeks apart)
Ability to understand English
Written informed consent for participation in the trial
Not taking hormone medication (HRT/COCP/’natural’ preparations) for 2 months prior to commencement in the trial
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
;
Age 18-45 years
Women with a diagnosis of POF within the last 36 months (with documented FSH level >30IU on 2 occassions 4-8 weeks apart)
Ability to understand English
Written informed consent for participation in the trial
Not taking hormone medication (HRT/COCP/’natural’ preparations) for 2 months prior to commencement in the trial
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Age less than 18 or over 45 years
Current desire for pregnancy is an exclusion criteria 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.
Women with absolute contraindications to hormone treatment will be excluded from the active treatment group (ie. personal history of thromboembolic disease, oestrogen dependent malignancies, personal history of focal migraine).
Women taking medication for high cholesterol or found to have raised cholesterol levels on initial assessment.
Untreated thyroid disease
;
Age less than 18 or over 45 years
Current desire for pregnancy is an exclusion criteria 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.
Women with absolute contraindications to hormone treatment will be excluded from the active treatment group (ie. personal history of thromboembolic disease, oestrogen dependent malignancies, personal history of focal migraine).
Women taking medication for high cholesterol or found to have raised cholesterol levels on initial assessment.
Untreated thyroid disease
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method