This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
Information provided by:
Ferring Pharmaceuticals Identifier:
First received: May 23, 2006
Last updated: May 18, 2011
Last verified: May 2011
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 (Participant, Care Provider)
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 ]

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
Experimental: 2
Daily Tablets Dose
Drug: Norprolac
Experimental: 3
Daily Tablets Dosing
Drug: Norprolac
Experimental: 4
Daily Tablets Dosing
Drug: Norprolac

Detailed Description:
No data to be entered.

Ages Eligible for Study:   21 Years to 37 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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 identifier: NCT00329693

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
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Clinical Development Support, Ferring Pharmaceuticals Identifier: NCT00329693     History of Changes
Other Study ID Numbers: FE999051 CS01
Study First Received: May 23, 2006
Last Updated: May 18, 2011

Additional relevant MeSH terms:
Ovarian Hyperstimulation Syndrome
Pathologic Processes
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on August 23, 2017