Tolerability of Quinagolide in a Dose-Titration Regimen in Oocyte Donors at Risk of Developing Ovarian Hyperstimulation Syndrome - Full Text View

Sponsored by:	Instituto Valenciano de Infertilidad, Spain
Information provided by:	Instituto Valenciano de Infertilidad, Spain
ClinicalTrials.gov Identifier:	NCT00665041

Purpose

Assess the tolerability of quinagolide 200 μg/day in a dose-titration regimen in oocyte donors undergoing controlled ovarian hyperstimulation and at risk of developing OHSS Secondary Objectives

Estimate the effects of a quinagolide dose-titration regimen compared to placebo in peritoneal fluid accumulation, incidence of ascites, OHSS symptoms and clinical laboratory parameters of haemoconcentration

Condition	Intervention	Phase
Ovarian Hyperstimulation Syndrome	Drug: Quinagolide	Phase II

Drug Information available for: Quinagolide Quinagolide hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	A Randomised, Double-Blind, Parallel Groups, Placebo-Controlled, Single-Centre Pilot Study Assessing the Tolerability of Quinagolide in a Dose-Titration Regimen in Oocyte Donors at Risk of Developing Ovarian Hyperstimulation Syndrome

Further study details as provided by Instituto Valenciano de Infertilidad, Spain:

Primary Outcome Measures:

To assess the tolerability of quinagolide 200 μg/day in a dose-titration regimen in oocyte donors undergoing controlled ovarian hyperstimulation and at risk of developing OHSS [ Time Frame: 21 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	May 2008
Estimated Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
PR1: Experimental	Drug: Quinagolide • Quinagolide 200 μg/day (dose titration from 50 μg/day to 100 μg/day to 200 μg/day), oral. Quinagolida tablets, 50 mcg. placebo, oral.
PL1: Placebo Comparator	Drug: Quinagolide • Quinagolide 200 μg/day (dose titration from 50 μg/day to 100 μg/day to 200 μg/day), oral. Quinagolida tablets, 50 mcg. placebo, oral.

Eligibility

Ages Eligible for Study:	21 Years to 34 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Signed Informed Consent Form, prior to screening evaluations
In good physical and mental health
Pre-menopausal females between the ages of 21-34 years (both inclusive) at the time of randomisation
Body mass index (BMI) between 18 and 29 kg/m2 (both inclusive)
Oocyte donor currently undergoing a controlled ovarian hyperstimulation cycle for assisted reproductive technologies (ART)
Antral follicle count ≥ 20

Exclusion Criteria:

Any exclusion criteria for oocyte donation
Known clinically significant systemic disease (e.g., insulin dependent diabetes)
Known endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney) which can compromise participation in the study
Undiagnosed vaginal bleeding
Known tumours of the ovary, breast, uterus, adrenal gland, pituitary or hypothalamus
Malformations of the sexual organs incompatible with pregnancy
Positive pregnancy test prior to start of stimulation
Treatment with other dopamine agonists (ATC code N04BC) or dopamine antagonists (ATC code N05A) within 2 months prior to randomisation
Treatment with any hormonal therapy (except for thyroid medication and oral contraceptives and except that routinely used as part of the controlled ovarian hyperstimulation cycle), anti-psychotics (ATC code N05A), anti-depressants (ATC code N06), anxiolytics (ATC code N05B), hypnotics and sedatives (ATC code N05C) or continuous use of prostaglandin inhibitors (non-steroid anti-inflammatory drugs (NSAIDs), including aspirin) within 2 weeks prior to randomisation
Known hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
Known history of psychotic disorders
Hypotension, orthostatic hypotension or recurrent syncope within 6 months prior to randomisation
Ongoing treatment of hypertension
Known previous poor tolerability to dopamine agonists
Known impaired hepatic or renal function
Current or past (12 months prior to randomisation) abuse of alcohol or drugs, and/or current (last month prior to randomisation) use of alcohol (more than 14 units per week)
Current or past (3 months prior to randomisation) smoking habit of more than 20 cigarettes per day
History of chemotherapy (except for gestational conditions) or radiotherapy
Use of any investigational drug during 3 months prior to randomisation
Previous participation in the study
Hypersensitivity to the active substance or to any of the excipients

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00665041

Contacts

Contact: Antonio Pellicer, MD PhD	34963050900 ext 11700	gferri@ivi.es
Contact: Leslie Atkinson, Ms	34963050900	latkinson@ivi.es

Locations

Spain
Instituto Valenciano de Infertilidad
Valencia, Spain, 46015

Sponsors and Collaborators

Instituto Valenciano de Infertilidad, Spain

More Information

Responsible Party:	Instituto Valenciano de Infertilidad ( Dr Antonio Pellicer )
Study ID Numbers:	VLC-CB-090108-001
Study First Received:	April 18, 2008
Last Updated:	April 23, 2008
ClinicalTrials.gov Identifier:	NCT00665041
Health Authority:	Spain: Comité Ético de Investigación Clínica

Study placed in the following topic categories:

Genital Diseases, Female
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 16, 2009