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

A Randomized, Double-blind, Placebo-controlled Parallel-group Study on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of UC1010 Administered Subcutaneously, Single-dosing in Healthy Women (Part 1) and Multiple Dosing in PMDD Women (Part 2) - Phase I/II Study

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01875718

Enrollment

146

Registered

2013-06-12

Start date

2013-01-31

Completion date

2014-06-30

Last updated

2015-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premenstrual Dysphoric Disorder

Brief 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.

Interventions

DRUGUC1010

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

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

Design outcomes

Primary

Measure	Time frame
Premenstrual symptom severity	Daily Record of Severity of Problems (DRSP) measured during 4-5 months

Secondary

Measure	Time frame
Number of subjects with adverse events	During 1.5 month (starting from first dose)

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026