Tolerability of Quinagolide in a Dose-titration Regimen in Oocyte Donors at Risk of Developing Ovarian Hyperstimulation Syndrome

NCT00665041 | Completed Phase 2

• 1 other identifier: VLC-CB-090108-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ovarian Hyperstimulation Syndrome

Outcome Measures

Primary Outcomes (1)

• 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

  21 days

Study Arms (2)

PR1

EXPERIMENTAL

Drug: Quinagolide

PL1

PLACEBO COMPARATOR

Drug: Quinagolide

Interventions

Quinagolide DRUG

• 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; PR1

Eligibility Criteria

• Age: 21 Years - 34 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Instituto Valenciano de Infertilidad, IVI VALENCIA: lead

Study Sites (1)

Instituto Valenciano de Infertilidad

Valencia, 46015, Spain

Location

MeSH Terms

Conditions

Ovarian Hyperstimulation Syndrome

Interventions

quinagolide

Condition Hierarchy (Ancestors)

Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 18, 2008
• First Posted: April 23, 2008
• Study Start: May 1, 2008
• Primary Completion: August 1, 2008
• Study Completion: October 1, 2008
• Last Updated: September 17, 2009

Record last verified: 2009-09

Locations

ES (1)