Overview

Trial to Assess the Clinical Efficacy and Safety of MSJ-0011 in Inducing Ovulation in Anovulatory or Oligo-ovulatory Japanese Women

Status:
Completed

Trial end date:
2014-12-01

Target enrollment:

Participant gender:

Summary

This is an open-label, parallel-group, randomized, multicenter Phase III trial to compare the efficacy and safety of a single 250 microgram (mcg) subcutaneous dose of MSJ-0011 to a single 5,000 international units (IU) intramuscular dose of urinary human chorionic gonadotropin (hCG) in inducing ovulation in Japanese women diagnosed with anovulation or oligo-ovulation. Ovulation induction therapy will be undertaken with follitropin alfa. The primary objective is to show that MSJ-0011 is non-inferior to urinary hCG, as assessed by the ovulation rate.

Phase:

Phase 3

Details

Lead Sponsor:

Merck KGaA
Merck KGaA, Darmstadt, Germany

Collaborator:

Merck Serono Co., Ltd., Japan

Treatments:

Chorionic Gonadotropin
Follicle Stimulating Hormone