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

This study has been completed.
Sponsor:
Information provided by:
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00329693
First received: May 23, 2006
Last updated: May 18, 2011
Last verified: May 2011
  Purpose

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.


Condition Intervention Phase
Ovarian Hyperstimulation Syndrome
Drug: Norprolac
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Prevention
Official Title: 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.

Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • OHSS [ Time Frame: 41 days after hCG injection ] [ Designated as safety issue: No ]

Enrollment: 182
Study Start Date: June 2006
Study Completion Date: May 2008
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Daily Tablets Dosing
Drug: Norprolac
Placebo
Experimental: 2
Daily Tablets Dose
Drug: Norprolac
Quinagolide
Experimental: 3
Daily Tablets Dosing
Drug: Norprolac
Quinagolide
Experimental: 4
Daily Tablets Dosing
Drug: Norprolac
Quinagolide

Detailed Description:

No data to be entered.

  Eligibility

Ages Eligible for Study:   21 Years to 37 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00329693

Locations
Spain
IVI Barcelona, Ronda General Mitre, 14
Barcelona, Spain, 08017
IVI Bilbao, Paseo Landabarri, 1
Leioa-Bizkaia, Spain, 48940
IVI Madrid, Santiago de Compostela, 88
Madrid, Spain, 28035
IVI Murcia, Navegante Macías del Poyo, 5, Edificio Delfín-Barrio La Flota
Murcia, Spain, 30007
IVI Sevilla, Avda. República Argentina, 58
Sevilla, Spain, 41011
IVI Valencia, Plaza de la Policía Local, 3
Valencia, Spain, 46015
IVI Vigo, Plaza Francisco Fernández del Riego, 7 (Plaza Elíptica)
Vigo (Pontevedra), Spain, 36203
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

No publications provided

Responsible Party: Clinical Development Support, Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00329693     History of Changes
Other Study ID Numbers: FE999051 CS01
Study First Received: May 23, 2006
Last Updated: May 18, 2011
Health Authority: Spain: Ministry of Health

Additional relevant MeSH terms:
Ovarian Hyperstimulation Syndrome
Syndrome
Adnexal Diseases
Disease
Endocrine System Diseases
Genital Diseases, Female
Gonadal Disorders
Ovarian Diseases
Pathologic Processes
Quinagolide
Dopamine Agents
Dopamine Agonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014