A Phase I/II Study to Evaluate UC1010 Treatment in Premenstrual Dysphoric Disorder (PMDD)

Umecrine AB

Status and phase: Completed; Phase 2; Phase 1

Conditions: Premenstrual Dysphoric Disorder

Treatments: Drug: Placebo; Drug: UC1010

Study type: Interventional

Funder types: Industry

Identifiers

NCT01875718

UM104

Details and patient eligibility

About

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.

Enrollment: 146 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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146 participants in 3 patient groups, including a placebo group

UC1010 low dose

Active Comparator group

Treatment:

Drug: UC1010

UC1010 high dose

Active Comparator group

Treatment:

Drug: UC1010

Vehicle

Placebo Comparator group

Treatment:

Drug: Placebo