Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01875718
Other study ID # UM104
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received May 29, 2013
Last updated January 19, 2015
Start date January 2013
Est. completion date June 2014

Study information

Verified date January 2015
Source Umecrine Mood AB
Contact n/a
Is FDA regulated No
Health authority Sweden: Medical Products Agency
Study type Interventional

Clinical Trial Summary

The study is a phase 1/2 study in two parts. In part 1, the primary objective is to assess the pharmacokinetics of UC1010 when administered subcutaneously as a single dose to healthy women. The safety and tolerability of UC1010 is also evaluated in study part 1.

In part 2, the primary objective is to assess the pharmacodynamic effect of UC1010 on premenstrual symptoms in women with Premenstrual Dysphoric Disorder (PMDD) when given during the luteal phase of the menstrual cycle. The pharmacodynamic effect is evaluated through the patients' daily ratings of premenstrual symptoms. In both study parts, two active treatment groups are compared to one placebo group.


Recruitment information / eligibility

Status Completed
Enrollment 146
Est. completion date June 2014
Est. primary completion date June 2014
Accepts healthy volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

Part 1 -Essentially healthy

Part 2 -Have PMDD according to DSM-IV verified in two menstrual cycles

Exclusion Criteria:

- steroid hormonal treatment during the previous three months

- treatment with psychopharmaceuticals or other treatment for PMS

- history of or a significant medical condition ongoing

- be pregnant or plan a pregnancy within the study period

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
UC1010

Placebo


Locations

Country Name City State
Sweden Umecrine Mood AB Solna

Sponsors (1)

Lead Sponsor Collaborator
Umecrine Mood AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Premenstrual symptom severity Daily Record of Severity of Problems (DRSP) measured during 4-5 months No
Secondary Number of subjects with adverse events During 1.5 month (starting from first dose)
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 NCT06136104 - The Effects of Mixhers HERTIME Supplements on Menstrual Symptoms N/A
Completed NCT01385709 - The Influence of the Menstrual Cycle on Lithium and Sertraline Blood Levels N/A