E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Healthy postmenopausal women receiving standard hormone replacement therapy are measured using positron emission tomography to investigate the effects of hormones on the cerebral serotonin-1A receptor. |
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MedDRA Classification |
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 |
The study investigates the influence of the steroid hormones estrogen and progesterone on the serotonin-1A receptor distribution in the human brain. The serotonin-1A receptor binding potential will be measured using positron emission tomography (PET) before and after 8 weeks of a daily hormone replacement therapy (HRT) in 30 medication-free postmenopausal women, which will be assigned to one of three treatment groups: one group (10 subjects) will be treated using a combination of oral estrogen (Progynova mite (R)) and micronized progesterone (Utrogestan(R)), the second group (10 subjects) receives an oral estrogen (Progynova mite (R)) and placebo, and the third group two placebos (matched to estrogen and progesterone administration). |
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E.2.2 | Secondary objectives of the trial |
A secondary objective of the trial is the assessment of effects of hormone replacement therapy on mood (depression and anxiety scores). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Postmenopausal females in good condition (over 14 months of amenorrhoea) • Age 50 - 65 years • Uni- or Multipara • Signed informed consent form • Consent not to participate in PET or SPECT studies with an added equivalence dose of over 15 mSv within 10 years following the final assessment of the participant in this study.
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E.4 | Principal exclusion criteria |
• Steroid hormone treatment within 6 months prior to the inclusion • Current substance abuse • History of any malign illness • Any implant or stainless steel graft • Concomitant neurological illness • Concomitant psychiatric disorder except anxiety disorders or depression • Treatment with a psychotropic agent targeting serotonin-1A and serotonin-2A receptors or the serotonin transporter such as buspirone, pindolol or SSRIs. • Clinically relevant abnormalities in the general physical examination and the routine laboratory screening • Concomitant major illness, especially: liver disease, disorder of the endocrine system, osteoporosis (when treated with vitamine D), any clinically relevant vascular or heart diseases • One of the following gynaecological diseases: ovariectomy, hysterectomy, endometriosis, myomatosis, cervical smear test: PAP > II • Extensive obesity (limiting factor is the bore of the MRI scanner) • Failures to comply with the study protocol or to follow the instructions of the investigating team. • Investigations using PET or SPECT within 10 years prior to the inclusion.
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E.5 End points |
E.5.1 | Primary end point(s) |
study ends with the second PET measurement after 8 weeks of hormone replacement therapy with either progesterone and estradiol / estradiol and placebo / or placebo. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Information not present in EudraCT |
E.6.5 | Efficacy | Information not present in EudraCT |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
the effects of IMPs on cerebral serotonin-1A distribution are investigated |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
the effects of IMPs on cerebral serotonin-1A distribution are investigated |
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E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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 | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
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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Trial ends after the second PET scan (8 weeks after start of the therapy) is completed and the final assessments are done (week 12-13 after inclusion). |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | |