Study Assessing the Effect of 3-week Treatment With One of Three Oral Doses of Quinagolide

May 18, 2011 updated by: Ferring Pharmaceuticals

A Randomised, Double-blind, Parallel Groups, Dose-finding, Placebo-controlled, Multi-centre, Proof of Concept Study Assessing the Effect of 3-wk Treatment With 1 of 3 Oral Doses of Quinagolide & Placebo in Preventing Ovarian Hyperstimulation Syndrome in Women Undergoing Controlled Ovarian Hyperstimulation.

Women included in this study are undergoing controlled ovarian hyperstimulation for assisted reproductive technologies (ART) and present with signs of moderate risk of developing OHSS.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

No data to be entered.

Study Type

Interventional

Enrollment (Actual)

182

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08017
        • IVI Barcelona, Ronda General Mitre, 14
      • Leioa-Bizkaia, Spain, 48940
        • IVI Bilbao, Paseo Landabarri, 1
      • Madrid, Spain, 28035
        • IVI Madrid, Santiago de Compostela, 88
      • Murcia, Spain, 30007
        • IVI Murcia, Navegante Macías del Poyo, 5, Edificio Delfín-Barrio La Flota
      • Sevilla, Spain, 41011
        • IVI Sevilla, Avda. República Argentina, 58
      • Valencia, Spain, 46015
        • IVI Valencia, Plaza de la Policía Local, 3
      • Vigo (Pontevedra), Spain, 36203
        • IVI Vigo, Plaza Francisco Fernández del Riego, 7 (Plaza Elíptica)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 37 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria

  1. Signed Informed Consent Form, prior to screening evaluations
  2. In good physical and mental health
  3. Pre-menopausal females between the ages of 21-37 years (both inclusive) at the time of randomisation
  4. Infertility for at least 1 year before randomisation, except for proven bilateral tubal infertility

Exclusion Criteria

  1. Any clinically significant systemic disease
  2. Endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney)
  3. History of recurrent miscarriage
  4. Undiagnosed vaginal bleeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 1
Daily Tablets Dosing
Drug: Norprolac
Placebo
Drug: Norprolac
Quinagolide
Experimental: 2
Daily Tablets Dose
Drug: Norprolac
Placebo
Drug: Norprolac
Quinagolide
Experimental: 3
Daily Tablets Dosing
Drug: Norprolac
Placebo
Drug: Norprolac
Quinagolide
Experimental: 4
Daily Tablets Dosing
Drug: Norprolac
Placebo
Drug: Norprolac
Quinagolide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
OHSS
Time Frame: 41 days after hCG injection
41 days after hCG injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ferring Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

May 23, 2006

First Submitted That Met QC Criteria

May 24, 2006

First Posted (Estimate)

May 25, 2006

Study Record Updates

Last Update Posted (Estimate)

May 19, 2011

Last Update Submitted That Met QC Criteria

May 18, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FE999051 CS01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ovarian Hyperstimulation Syndrome

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sweden

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe