E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Premenstrual dysphoric disorder (PMDD) |
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E.1.1.1 | Medical condition in easily understood language |
Condition in which a woman has severe depression symptoms, irritability, and tension before menstruation |
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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 | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10051537 |
E.1.2 | Term | Premenstrual dysphoric disorder |
E.1.2 | System Organ Class | 10038604 - Reproductive system and breast disorders |
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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 |
The primary objective of the study is to evaluate the effect of two doses of UC1010 on premenstrual symptoms in women with PMDD in comparison to placebo.
The effect of UC1010 given repeatedly to women with PMDD as subcutaneous injections during the luteal phase of three consecutive menstrual cycles will be compared with a corresponding placebo administration. Effect will be assessed by comparison of symptoms recorded daily by the patients using a validated rating scale also used for the diagnosis of PMDD.
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E.2.2 | Secondary objectives of the trial |
The secondary objective of the study is to evaluate safety and tolerability of repeated subcutaneous administration of UC1010 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Subjects must: ○ be a woman between 18-45 years of age ○ have a regular menstrual cycle of 24-35 days cycle ○ use a highly effective or acceptable method of contraception, e.g. male or female condom, non-hormonal IUD, be truly sexually abstinent, or subject or her partner has been surgically sterilized ○ have PMDD according to DSM-5 verified in two menstrual cycles
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E.4 | Principal exclusion criteria |
Most important criteria. Subjects must not: ○ have any steroid hormonal treatment (including hormonal IUD, vaginal ring, cream or dermal patch) during the previous 3 months before the first study visit, ○ have been treated with any psychopharmaceuticals during the previous 3 months before the first study visit, unless for SSRI where 1 month wash-out time is acceptable, ○ have treatment during the previous 3 months before the first study visit with over-the-counter or prescription drugs for PMS symptoms, ○ have a significant medical condition ongoing in the opinion of the Investigator, including any chronic psychiatric disease with a relapse in the past year, ○ have a drug or alcohol, abuse or dependency, ongoing or have a history of such abuse or dependency during the last 2 years, ○ be pregnant, given birth within the last 4 months before the first study visit, be breast-feeding or intending to become pregnant during the study period, ○ have a clinically relevant finding on the physical examination or blood testing.
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary analysis will be change from baseline in late luteal phase Total symptom score (LmaxSum21) determined as the average sum score of all 21 questions (Q) recorded during the worst 5 consecutive days during Day -6 to Day 1.
The DRSP variables will be calculated as the difference between the average of two diagnostic cycles (D) and the average of the two last treatment cycles in the UC1010-treated (A), and in placebo-treated patients (P), i.e. Lmax (D-A vs. D-P).
Only ovulatory cycles (confirmed by elevated progesterone levels) will be used for assessment of treatment effects.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
During treatment: -during the worst 5 consecutive days during Day -6 to Day 1 for each patient -during ovulatory cycles |
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E.5.2 | Secondary end point(s) |
The corresponding Lmax for the Impairment score, i.e. sum scores of Q22-24 (Lmax Impairment) will be calculated accordingly.
The corresponding Lmax for the PMDD cardinal symptom score, i.e. sum Q1-8 (Lmax Sum1a4b) including depression, anxiety, lability and anger/irritability scores will be calculated accordingly.
Symptom severity will be assessed using the CGI-S scale, and change in symptom severity from baseline to after completion of the three treatment cycles will be assessed using the CGI-I scale where subjects with a score of 1 (very much improved) or 2 (much improved) are defined as responders. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
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) | 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) | 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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 14 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Germany |
Poland |
Sweden |
United Kingdom |
United States |
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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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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 | 1 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 8 |
E.8.9.2 | In all countries concerned by the trial days | 0 |