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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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24 June 2013 |
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Main ID: |
EUCTR2008-002599-86-GB |
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Date of registration:
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15/04/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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
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Scientific title:
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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 |
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Date of first enrolment:
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03/03/2009 |
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Target sample size:
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66 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-002599-86 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: yes
Other specify the comparator: no treatment group
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Phase:
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Countries of recruitment
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
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
Exclusion criteria:
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 minimum:
Age maximum:
Gender:
Female: yes
Male: no
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Health Condition(s) or Problem(s) studied
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Premature ovarian failure
MedDRA version: 9.1
Level: LLT
Classification code 10036602
Term: Premature ovarian failure
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Intervention(s)
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Trade Name: Nuvelle (FemTab Sequi)
Pharmaceutical Form: Tablet
INN or Proposed INN: ESTRADIOL VALERATE
CAS Number: 979328
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.0-
INN or Proposed INN: LEVONORGESTREL
CAS Number: 797637
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 75-
Trade Name: microgynon 30
Pharmaceutical Form: Tablet
INN or Proposed INN: LEVONORGESTREL
CAS Number: 797637
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 150-
INN or Proposed INN: Ethinylestradiol
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 30-
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Primary Outcome(s)
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Secondary Objective: To compare the effects of active treatment (with HRT or COCP) of POF with no treatment of POF on serum markers of cardiovascular disease, symptom control, depression score and ovarian function and volume over a 2 year period.
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Primary end point(s): Bone density at the lumbar spine and hip (assessed by DXA bone scan)
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Main Objective: To compare the effects of active treatment (with HRT or COCP) of POF with no treatment of POF on bone density.
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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