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

This study has been completed.

First Received: May 23, 2006 Last Updated: September 8, 2009 History of Changes

Sponsored by:	Ferring Pharmaceuticals
Information provided by:	Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00329693

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 II

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Parallel Assignment
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.

Resource links provided by NLM:

Drug Information available for: Quinagolide Quinagolide hydrochloride

U.S. FDA Resources

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
1: Placebo Comparator Daily Tablets Dosing	Drug: Norprolac Placebo
2: Experimental Daily Tablets Dose	Drug: Norprolac Quinagolide
3: Experimental Daily Tablets Dosing	Drug: Norprolac Quinagolide
4: Experimental 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

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

Exclusion Criteria

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

Contacts and Locations

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 Vigo, Plaza Francisco Fernández del Riego, 7 (Plaza Elíptica)
Vigo (Pontevedra), Spain, 36203
IVI Sevilla, Avda. República Argentina, 58
Sevilla, Spain, 41011
IVI Valencia, Plaza de la Policía Local, 3
Valencia, Spain, 46015
IVI Murcia, Navegante Macías del Poyo, 5, Edificio Delfín-Barrio La Flota
Murcia, Spain, 30007

Sponsors and Collaborators

Ferring Pharmaceuticals

Investigators

Study Director:

Clinical Development Support

Ferring Pharmaceuticals

More Information

No publications provided

Responsible Party:	Ferring Pharmaceuticals ( Hjort, Director )
Study ID Numbers:	FE999051 CS01
Study First Received:	May 23, 2006
Last Updated:	September 8, 2009
ClinicalTrials.gov Identifier:	NCT00329693 History of Changes
Health Authority:	Spain: Ministry of Health

Study placed in the following topic categories:

Genital Diseases, Female
Signs and Symptoms
Neurotransmitter Agents
Dopamine
Quinagolide
Gonadal Disorders

Ovarian Hyperstimulation Syndrome
Endocrine System Diseases
Dopamine Agents
Endocrinopathy
Ovarian Diseases
Dopamine Agonists

Additional relevant MeSH terms:

Neurotransmitter Agents
Disease
Quinagolide
Molecular Mechanisms of Pharmacological Action
Gonadal Disorders
Physiological Effects of Drugs
Endocrine System Diseases
Ovarian Diseases

Dopamine Agonists
Pharmacologic Actions
Adnexal Diseases
Genital Diseases, Female
Pathologic Processes
Syndrome
Ovarian Hyperstimulation Syndrome
Dopamine Agents

ClinicalTrials.gov processed this record on September 11, 2009