E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Premature ovarian failure.
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E.1.1.1 | Medical condition in easily understood language |
Menopause in women under the age of 45 years - premature failure of the ovaries. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Hormonal diseases [C19] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10036602 |
E.1.2 | Term | Premature ovarian failure |
E.1.2 | System Organ Class | 100000004872 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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.
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary outcome measure for the study is the vascular elasticity. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
This end point will be measured at 0, 3, 6 and 12 months. |
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E.5.2 | 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.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
These end point will be measured at 0, 3, 6 and 12 months. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
To determine the effects of progestogens on the CVS health of women with premature ovarian failure |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |