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
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
-
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.