E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Premenstrual Dysphoric Disorder (PMDD) |
|
E.1.1.1 | Medical condition in easily understood language |
Severe premenstrual depression and anxiety |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13] |
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 |
To investigate the pharmacokinetic properties of subcutaneously administered UC1010 and the pharmacodynamic effect of UC1010 in women with PMDD |
|
E.2.2 | Secondary objectives of the trial |
The secondary objectives are to investigate the safety and tolerability of subcutaneously administered UC1010 |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
For part 1, the subjects must: − be essentially healthy For part 2, the subjects must: − have PMDD according to DSM-IVa verified in two menstrual cycles
In addition, the subjects must: − be a woman between 18-45 years of age − have a regular menstrual cycle − use barrier contraception or non-hormonal IUD, be abstinent or surgically sterilized
|
|
E.4 | Principal exclusion criteria |
Subjects must not: − have or have had any steroid hormonal treatment during the previous three months − have or have had treatment with psychopharmaceuticals during the previous month − have a history of or have a significant medical condition ongoing, including any psychiatric disease − have a history of or have a drug or alcohol abuse or use more than 30 g of alcohol per day − be pregnant or plan a pregnancy within the study period − participate concurrently in any other clinical trial |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Study part 1: Plasma concentrations of the IMP Study part 2: Symptom assessment using a validated daily rating scale (DRSP) containing the demanded symptoms in DSM-IV for diagnosis of PMDD |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Study part 1: Up to 72 hours after single injection Study part 2: During one menstrual cycle of treatment and during one menstrual cycle of non-treatment |
|
E.5.2 | Secondary end point(s) |
Physical examinations, inspection of injection sites, safety blood sampling and AE reporting
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
During and up to one month after treatment. |
|
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 | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
PK of new administration route |
|
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 9 |
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
|
|
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 | |
E.8.9.1 | In the Member State concerned days | |