Premature Ovarian Insufficiency Study of Effectiveness of hormonal therapy
Premature ovarian insufficiency
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 Insufficiency (POI) in women, with an internal pilot phase to review the expected rate of recruitment at 18 months. Patients will be recruited in secondary care clinics (which include gynaecology, fertility, specialist menopause) throughout the UK. Patients will have an initial diagnosis of POI or will be attending routine POI follow-up. Patients will be given a patient information sheet and time to consider the study. All participants will attend one clinic visit at baseline. This is not a study-specific visit as it is usual practice for women to have a clinic visit after a POI diagnosis to discuss treatment options. During this visit eligibility will be checked and consent will be obtained (if preferred consent may also be obtained electronically). Baseline data will be recorded including height, weight, blood pressure and a DEXA bone density measurement (if not already done within the last 6 months). Participants will also complete 3 questionnaires; 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 obtained electronically. A video or telephone consultation would replace a clinic visit and will be in accordance with local NHS policy. Participants will be randomised on a 1:1 ratio, minimised by recruitment site, age at randomisation, body mass index and smoking status to one of two treatment groups: Group A: COC – Women allocated the COC should be prescribed 30 µg ethinyloestradiol with 150 µg levonorgestrel (Microgynon 30 or equivalent) as an extended regimen; the suggested regimen is 63 days with 7 days hormone-free interval. Alternative formulations can be prescribed if required but must contain 30 µg ethinyloestra
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
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