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| Name | Class |
|---|---|
| Ergomed | INDUSTRY |
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The objective of this phase IIb study is to evaluate the effect and safety of Sepranolone (UC1010) on premenstrual symptoms in women with Premenstrual Dysphoric Disorder (PMDD). Patients will be taking Sepranolone or Placebo (blinded to patient and study doctor) during the two weeks preceding the menstruation of three menstrual cycles. Effect (change from baseline) will be assessed by comparison of symptoms recorded daily by the patients using a validated rating scale for assessment of PMDD symptoms. Sepranolone is an endogenous steroid.
The objective of this phase IIb study is to evaluate the effect and safety of two doses of Sepranolone (UC1010) on premenstrual symptoms in women with Premenstrual Dysphoric Disorder (PMDD) in comparison to placebo, administrated during the luteal phase of three consecutive menstrual cycles. Effect will be assessed by comparison of symptoms recorded daily by the patients using a validated rating scale for assessment of PMDD symptoms and impairment of symptoms on daily life of the patients. The scale is Daily Record of Severity of Problems (DRSP). Preceding the treatment period, the diagnosis of PMDD will be established in the study participants by at lest two menstrual cycles of prospective DRSP ratings by the patients. This period will also constitute the baseline data. The effect of study medication will be assessed as the change in symptoms from baseline to during treatment. The Total symptom score of the DRSP will constitute the primary variable and the late luteal phase ratings in the respective menstrual cycles, before and during treatment, will be used.
The study will also include a follow-up (no treatment) cycle before patients final visit.
The study is conducted in four European countries (Sweden, Germany, Poland and United Kingdom) and will include up to 225 patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sepranolone (UC1010) low dose | Experimental | Sepranolone (UC1010) low dose administered subcutaneously (SC) during the luteal phase |
|
| Sepranolone (UC1010) high dose | Experimental | Sepranolone (UC1010) high dose administered subcutaneously (SC) during the luteal phase |
|
| Placebo | Placebo Comparator | Placebo administered subcutaneously (SC) during the luteal phase |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sepranolone (UC1010) low dose | Drug | Subcutaneous (SC) administration |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Effect on DRSP Total symptom score | Change in DRSP Total symptom score (Daily Record of Severity of Problems) measured during the luteal phase (i.e. the week before menstruation) before and during treatment | Baseline luteal phase score (average from two menstrual cycles) vs. luteal phase score during treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | Recording of adverse events | Starting from first dose given until 1 months after treatment stop |
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Main Inclusion Criteria:
Main Exclusion Criteria:
Woman with regular menstrual cycles
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| Name | Affiliation | Role |
|---|---|---|
| Shaughn O'Brien, MD | Obstetrics and Gynaecology Keele University School of Medicine and University Hospitals of North Staffordshire | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zentrum für Klinische Forschnung | Bad Homburg | Germany | ||||
| Emovis |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28319848 | Background | Bixo M, Ekberg K, Poromaa IS, Hirschberg AL, Jonasson AF, Andreen L, Timby E, Wulff M, Ehrenborg A, Backstrom T. Treatment of premenstrual dysphoric disorder with the GABAA receptor modulating steroid antagonist Sepranolone (UC1010)-A randomized controlled trial. Psychoneuroendocrinology. 2017 Jun;80:46-55. doi: 10.1016/j.psyneuen.2017.02.031. Epub 2017 Mar 1. |
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| Sepranolone (UC1010) high dose |
| Drug |
Subcutaneous (SC) administration |
|
| Placebo | Drug | Subcutaneous (SC) adminstration |
|
| Berlin |
| Germany |
| Medizentrum Essen Borbeck | Essen | Germany |
| Klinische Forschung Karlsruhe GmbH | Karlsruhe | Germany |
| Praxis Dr. Steinwachs | Nuremberg | Germany |
| Centrum Kliniczno-Badawcze | Elblag | Poland |
| Centrum Medyczne Angelius Provita | Katowice | Poland |
| ProCreative | Krakow | Poland |
| Karolinska University Hospital | Stockholm | 17176 | Sweden |
| Liverpool Women's NHS Foundation Trust | Liverpool | United Kingdom |
| Imperial College London | London | United Kingdom |
| Obstetrics and Gynaecology Keele University School of Medicine and University Hospitals of North Staffordshire | Stoke-on-Trent | ST4 6QG | United Kingdom |
| ID | Term |
|---|---|
| D065446 | Premenstrual Dysphoric Disorder |
| ID | Term |
|---|---|
| D011293 | Premenstrual Syndrome |
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D011280 | Pregnanolone |
| ID | Term |
|---|---|
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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