Clinical Trials Logo
  1. Home
  2. Premenstrual Dysphoric Disorder
  3. NCT03697265

A Study of Efficacy and Safety of Sepranolone (UC1010) in Patients With Premenstrual Dysphoric Disorder (PMDD)

Premenstrual Dysphoric Disorder Clinical Trial

Official title:
A Phase II, Randomised, Double-blind, Placebo-controlled, Parallel Group, Multicentre Study Investigating Efficacy and Safety of Sepranolone (UC1010) in Patients With Premenstrual Dysphoric Disorder (PMDD)

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03697265
Study type Interventional
Source Asarina Pharma
Contact
Status Completed
Phase Phase 2
Start date April 20, 2018
Completion date October 23, 2020
View Details
See also
  Status Clinical Trial Phase
Completed NCT03862469 - Premenstrual Hormonal and Affective State Evaluation (PHASE) Project N/A
Active, not recruiting NCT00536198 - Evaluating the Effectiveness of Sertraline in Treating Women With Premenstrual Dysphoric Disorder N/A
Completed NCT03449979 - Single Session of tACS in a Depressive Episode N/A
Completed NCT00516113 - A Placebo-Controlled Study to Investigate the Onset of Action of Paroxetine in Premenstrual Dysphoria Phase 4
Recruiting NCT05098574 - Oral Contraceptives for Treating Premenstrual Dysphoric Disorder in Bipolar Disorder Phase 2
Withdrawn NCT04123483 - EnBrace HR for PMS With Prominent Mood Symptoms or Menstrual Related Mood Disorders Phase 4
Completed NCT00518570 - Levetiracetam in the Treatment of Patients With Premenstrual Dysphoric Disorder (PMDD) N/A
Not yet recruiting NCT01217775 - Intranasal PH80 Spray for Acute Management of the Symptoms of Premenstrual Dysphoric Disorder Phase 3
Terminated NCT02362191 - Targeting Inter-Hemispheric Alpha Coherence With tACS To Treat PMDD N/A
Completed NCT00678574 - The Role of GABA and Neurosteroids in Premenstrual Dysphoric Disorder Phase 4
Active, not recruiting NCT05327075 - Premenstrual Dysphoric Disorder:Knowledge,Attitude and Practice Among Egyptian Females
Not yet recruiting NCT02448836 - Deep Transcranial Magnetic Stimulation (dTMS) for the Treatment of Premenstrual Dysphoric Disorder (PMDD) N/A
Completed NCT01799733 - Alternative Treatments for Premenstrual Dysphoric Disorder N/A
Completed NCT06227676 - Effect of 'Cramp Bites' on Period Cramps in Women Aged 18-25 Phase 2/Phase 3
Active, not recruiting NCT02508103 - Emotional Processing and Oxytocin Mechanisms in Premenstrual Dysphoric Disorder: A Pilot Study Phase 2/Phase 3
Completed NCT00927095 - Continuous Oral Contraceptive Treatment in Premenstrual Dysphoric Disorder (PMDD) Phase 4
Completed NCT00089414 - Treatment of Menstrually Related Disorders With Continuous v. Interrupted Oral Contraceptives Phase 2
Not yet recruiting NCT06462391 - Adapting and Piloting Acceptance and Commitment Therapy (ACT) for Severe Premenstrual Mood Symptoms N/A
Completed NCT01875718 - A Phase I/II Study to Evaluate UC1010 Treatment in Premenstrual Dysphoric Disorder (PMDD) Phase 1/Phase 2
Completed NCT06136104 - The Effects of Mixhers HERTIME Supplements on Menstrual Symptoms N/A