Status:
COMPLETED
Study Assessing the Effect of 3-week Treatment With One of Three Oral Doses of Quinagolide
Lead Sponsor:
Ferring Pharmaceuticals
Conditions:
Ovarian Hyperstimulation Syndrome
Eligibility:
FEMALE
21-37 years
Phase:
PHASE2
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.
Detailed Description
No data to be entered.
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
182 Patients enrolled
Trial Details
Trial ID
NCT00329693
Start Date
June 1 2006
End Date
May 1 2008
Last Update
May 19 2011
Active Locations (7)
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1
IVI Barcelona, Ronda General Mitre, 14
Barcelona, Spain, 08017
2
IVI Bilbao, Paseo Landabarri, 1
Leioa-Bizkaia, Spain, 48940
3
IVI Madrid, Santiago de Compostela, 88
Madrid, Spain, 28035
4
IVI Murcia, Navegante Macías del Poyo, 5, Edificio Delfín-Barrio La Flota
Murcia, Spain, 30007