Premature ovarian failure. MedDRA version: 14.1 Level: LLT Classification code 10036602 Term: Premature ovarian failure System Organ Class: 100000004872
Conditions
Sponsors
King's College Hospital NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Females aged between 16 and up to 45 years. 2. Confirmed diagnosis of POF with a history of oligomenorrhoea/amenorrhoea for at least 6 months and elevated gonadotrophins = 30mlU/ml on two separate occasions. 3. Willingness to participate. 4. No concomitant co-morbidities that would contraindicate the use of hormonal preparations such as unexplained bleeding, breast cancer, endometrial cancer or thromboembolic disease. Are the trial subjects under 18? yes Number of subjects for this age range: 90 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 90 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Age under 16 or over 45 years. 2. Pregnant or lactating females. 3. Contraindication to the use of hormonal preparations, such as a history of cerebrovascular disease and thromboembolic disease. 4. Factors present in the past medical history that would contribute to the increased risk of cardiovascular disease, such as, previous myocardial infarction, angina, diabetes, kidney disease, hyperlipidaemia or hypertension. 5. Personal history of thromboembolic episode or known thrombophilia that would impact on the results of the thrombogenic profile. 6. Presence of any other clinically significant medical condition, as determined by the investigators. 7. Known Porphyria. 8. Known liver disease. 9. Known past or suspected breast cancer. 10. Undiagnosed vaginal bleeding. 11. Genital tract carcinoma. 12. Thrombophlebitis. 13. Smokers. 14. Body mass index >35. 15. Known hypertensive disease. 16. Women on concomitant medications that could influence the results, such as anti-hypertensives or anticoagulants. 17. Known intolerance, allergy or contraindication to the use of oestrogen and/or progesterone. 18. Known hypersensitivity to the active substances or excipients contained within the utrogestan, Medroxyprogesterone Acetate or Evorel patches 19. Known allergy to peanuts or soya.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Objective: To assess the effect of micronized progesterone and medroxy progesterone acetate on vascular elasticity. This will be assessed by examining the changes in pulse wave analysis in women with premature ovarian failure receiving combined oestrogen/progestogen HRT. ; Secondary Objective: Secondary Objective: To assess the effect of micronized progesterone and medroxy progesterone acetate on: 1. Pulse wave velocity. 2. Lipid profiles. 3. Coagulation cascade. 4. Side-effect profile and women’s satisfaction with their HRT regimen. ;Primary end point(s): The primary outcome measure for the study is the vascular elasticity. ;Timepoint(s) of evaluation of this end point: This end point will be measured at 0, 3, 6 and 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Mean changes in the pulse waveform patterns 2. Mean changes in the lipid profiles 3. Changes in the coagulation factors 4. Effects on the quality of life of these women. ;Timepoint(s) of evaluation of this end point: These end point will be measured at 0, 3, 6 and 12 months. | — |
Countries
United Kingdom
Contacts
Public ContactHaitham Hamoda
King's College Hospital NHS Foundation Trust
Outcome results
None listed