ISRCTN91141124
Active, not recruiting
Phase 3
Premature Ovarian Insufficiency Study of Effectiveness of hormonal therapy
niversity College London0 sites480 target enrollmentSeptember 9, 2021
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversity College London
- Enrollment
- 480
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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
Outcomes
Primary Outcomes
Not specified
Similar Trials
Not yet recruiting
Phase 4
Prospective Interventional Study on Ovarian Function Preservation by Endometrioma Ablation Using the Thulium YAG LaserOvarian Endometriomaovarian endometrioma, infertilityD004715JPRN-jRCT1052230182Kawahara Naoki10
Recruiting
Not Applicable
Observational pilot study on Diminished ovarian reserve in infertilityPregnancy, childbirth and the puerperiumKCT0002572Korea Institute of Oriental Medicine30
Not yet recruiting
Not Applicable
A Multicenter Observational Study on the Development and Health Effects of Premature Ovarian InsufficiencyPremature Ovarian InsufficiencyNCT06067529Women's Hospital School Of Medicine Zhejiang University400
Active, not recruiting
Phase 2
A Phase II Study of Ovarian Function Suppression And ExemesTane with or without PalbocIclib in PreMenopausal Women with ER positive / HER-2 negative MetAstatic Breast Cancer (FATIMA)Metastatic Breast Cancer – OncologyNot applicableT51.2LBCTR2019020181AMCI (Africa Middle East Cancer Intergroup)/Investigator Initiated Research160
Completed
Not Applicable
Steroid Therapy in Autoimmune Premature Ovarian FailureAutoimmune DiseaseInfertilityPremature Ovarian FailureNCT00001306Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)33