Study Assessing the Effect of 3-Week Treatment With One of Three Oral Doses of Quinagolide - Full Text View

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

Drug Information available for: Quinagolide Quinagolide hydrochloride

U.S. FDA Resources

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.

Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:

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

Estimated Enrollment:	200
Study Start Date:	May 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

Madrid, Spain

Sponsors and Collaborators

Ferring Pharmaceuticals

Investigators

Study Director:

Joan-Carles Arce

Ferring A/S

More Information

Responsible Party:	IPS ( Jeppe Voss, Clinical Research Manager, Clinical Science, Clin R&D, Obgyn )
Study ID Numbers:	FE999051 CS01
Study First Received:	May 23, 2006
Last Updated:	May 28, 2008
ClinicalTrials.gov Identifier:	NCT00329693
Health Authority:	Spain: Ministry of Health

Study placed in the following topic categories:

Genital Diseases, Female
Signs and Symptoms
Dopamine
Quinagolide
Gonadal Disorders

Ovarian Hyperstimulation Syndrome
Endocrine System Diseases
Endocrinopathy
Ovarian Diseases

Additional relevant MeSH terms:

Neurotransmitter Agents
Pathologic Processes
Disease
Molecular Mechanisms of Pharmacological Action
Syndrome

Physiological Effects of Drugs
Dopamine Agents
Dopamine Agonists
Pharmacologic Actions
Adnexal Diseases

ClinicalTrials.gov processed this record on January 15, 2009