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Gonadorelin

GnRH, Luteinizing Hormone-Releasing Hormone, LHRH, Factrel

Quick Stats
Studies 192
Trials 100
Completed PHASE2, PHASE3 INTERVENTIONAL NCT00296465

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Three Dosage Strengths of Pulsatile GnRH

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

This study will be performed in approximately 132 women with anovulatory/oligoovulatory infertility.

Detailed Description

This multicenter, randomized, double-blind, placebo-controlled study will be performed in approximately 132 women with anovulatory/oligoovulatory infertility. The treatment duration will be approximately 4 weeks with pulsatile GnRH or placebo and 5 days with Clomiphene Citrate or placebo. All subjects will be screened based on inclusion/exclusion criteria, medical/infertility history and general safety assessments. Subjects that complete screening will be dispensed 100 mg of oral progesterone twice a day for 10 days to induce uterine bleeding. On Cycle Day 5 from the start of bleeding the subject will be randomly assigned to 1 of 7 treatment groups. All subjects will be monitored weekly throughout the 4 week treatment period for ovulation and intercourse will be timed. All subjects will be required to return to the study center for a total of 8 visits. In addition, all subjects with a confirmed clinical pregnancy will be monitored until fetal heartbeat is confirmed at approximately 5-6 weeks gestation

Interventions

Name: Pulsatile gonadotropin-releasing hormone (GnRH)
Type: DRUG
Description: Dosages as specified, administered either subcutaneously (SC) or intraveneously (IV) as specified, via portable infusion pump in a pulsatile fashion (every 90 minutes) for 4 weeks
Name: Clomiphene Citrate
Type: DRUG
Description: Oral clomiphene citrate (over encapsulated) for 5 days
Name: Placebo Pulsatile GnRH
Type: DRUG
Description: Administered either intravenously or subcutaneously via portable infusion pump in a pulsatile fashion (every 90 minutes) for 4 weeks
Name: Placebo Clomiphene Citrate
Type: DRUG
Description: oral placebo clomiphene citrate for 5 days

Primary Outcomes

Measure: Pregnancy rate
TimeFrame: Day 16
Description:

Trial Information

NCT ID

NCT00296465

Status

Completed

Study Type

INTERVENTIONAL

Phases

PHASE2, PHASE3

Sponsor

Ferring Pharmaceuticals

Last Updated

December 15, 2025