Premature ovarian insufficiency Nutritional, Metabolic, Endocrine Primary ovarian failure
Conditions
Interventions
The study is a multi-centre two-arm open randomised, parallel, superiority study of combined oral contraceptive (COC) versus hormone replacement therapy (HRT) for the treatment of Premature Ovarian In
about their quality of life, work productivity and sexual function. Where a face to face visit is not possible e.g. as a result of measures implemented during the COVID-19 pandemic, consent may be obt
Sponsors
University College London
Eligibility
Sex/Gender
Female
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 03/01/2024: 1. Diagnosis of POI (based on NICE guidelines) or with an established diagnosis of POI (e.g. Turner Syndrome, surgical menopause) 2. Will be aged older than 18 and less than 40 years at randomisation 3. Not intending to become pregnant within 12 months 4. Not taken any HRT, COC or testosterone treatment for the last 4 weeks or willing to stop HRT/COC/testosterone treatment for a minimum period of 4 weeks prior to randomisation 5. Must provide written/electronic informed consent Previous inclusion criteria: 1. Diagnosis of POI 2. Will be aged older than 18 and less than 40 years at randomisation 3. Not intending to become pregnant within 12 months 4. Not taken any HRT or COC treatment for the last 4 weeks or willing to stop HRT/COC treatment for a minimum period of 4 weeks prior to randomisation 5. Must provide written/electronic informed consent
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 03/01/2024: 1. Contraindications to HRT or COC 2. Taking other drugs affecting BMD e.g. bisphosphonates and long-term use of systemic corticosteroids (dietary supplements e.g. Vitamin D, calcium and short course of corticosteroids are permitted) 3. Receiving estrogens for puberty induction 4. Participation in a clinical research study (currently or in the last 3 months) involving testosterone treatments or novel HRT formulations Previous exclusion criteria: 1. Contraindications to HRT or COC 2. Taking other drugs affecting BMD e.g. bisphosphonates and long-term use of systemic corticosteroids (dietary supplements e.g. Vitamin D, calcium and short course of corticosteroids are permitted) 3. Receiving sex steroid hormones for puberty induction 4. Participation in a clinical research study (currently or in the last 3 months) involving testosterone treatments or novel HRT formulations
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absolute bone mineral density (BMD (g/cm2)) at 2 years from the date of randomisation, assessed by a standard DEXA scan of the lumbar spine. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 29/01/2025: 1. Absolute BMD (g/cm2) in lumbar spine at 1 and 2 years. 2. Absolute BMD (g/cm2) in hip at 1 and 2 years. 3. T-score category (=-2.5, > -2.5 to = -1, > -1) for BMD at lumbar spine at 1and 2 years. 4. T-score category for BMD at hip at 1 and 2 years. 5. Individual domains (vasomotor, psychosocial, physical and sexual) and summary score of Menopause Specific Quality of Life (MENQOL)-Intervention questionnaire at 3, 6 and 12 months then annually. 6. Sexual function (pleasure, discomfort and frequency) measured by the Sexual Activity Questionnaire (SAQ) at 3, 6, 12 months then annually. 7. Work Productivity (absenteeism, presenteeism, work productivity loss and activity impairment), using the Work Productivity and Activity Impairment (WPAI) Scale (Specific health Problem) at 3, 6, 12 months then annually. 8. Weight (kg) at 3, 6, and 12 months then annually. 9. Systolic blood pressure (mm Hg) at 3, 6 and 12 months then annually. 10. Diastolic blood pressure (mm Hg) at 3, 6 and 12 months then annually. 11. Pregnancy and pregnancy outcome. 12. Satisfaction with treatment, on a 5-point Likert scale at 3, 6 and 12 months then annually. 13. Change or cessation of treatment at 3, 6 and 12 months then annually. 14. Adverse events at 3, 6 and 12 months and then annually. Specific minor-side effects collected will include breast pain, nausea, headaches, skin or hair changes and unscheduled bleeding as well as more serious events such as venous thromboembolism. All serious adverse events will be collected and causal relationship with treatment considered. 15. Diagnosis of cancer, cardiovascular disease, cognitive impairment, bone fractures and mortality will be collected from routine data sources at 5 years. Sub-study outcome measures 1. Bone metabolism markers will be collected on a subset of women from selected clinics, at 3 and 12 months (not reported until the end of the study). 2. Cardiovascular markers. Fasting lipids, | — |
Countries
England, Scotland, United Kingdom
Contacts
Public ContactElisha Manasoko
Outcome results
None listed