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

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ClinicalTrials.gov Identifier: NCT00329693
Recruitment Status : Completed
First Posted : May 25, 2006
Last Update Posted : May 19, 2011
Sponsor:
Information provided by:
Ferring Pharmaceuticals

Brief Summary:
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 or disease Intervention/treatment Phase
Ovarian Hyperstimulation Syndrome Drug: Norprolac Phase 2

Detailed Description:
No data to be entered.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 182 participants
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.
Study Start Date : June 2006
Actual Primary Completion Date : August 2007
Actual Study Completion Date : May 2008

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. OHSS [ Time Frame: 41 days after hCG injection ]


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Ages Eligible for Study:   21 Years to 37 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Clinical Development Support, Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00329693     History of Changes
Other Study ID Numbers: FE999051 CS01
First Posted: May 25, 2006    Key Record Dates
Last Update Posted: May 19, 2011
Last Verified: May 2011

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