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

• Sponsor: Ferring Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00329693
• Collaborator: (none)
• Enrollment: 182
• Locations: 7
• Arms: 4
• Duration (Months): 23
• Patients Per Site: 26
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ovarian Hyperstimulation Syndrome	Drug: Norprolac; Drug: Norprolac; Drug: Norprolac; Drug: Norprolac	Phase 2

Detailed Description

No data to be entered.

Study Design

• Study Type: Interventional
• Actual Enrollment: 182 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Prevention
• 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.
• Study Start Date: Jun 1, 2006
• Actual Primary Completion Date: Aug 1, 2007
• Actual Study Completion Date: May 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: 1 Daily Tablets Dosing	Drug: Norprolac; Placebo
Experimental: 2 Daily Tablets Dose	Drug: Norprolac; Quinagolide
Experimental: 3 Daily Tablets Dosing	Drug: Norprolac; Quinagolide
Experimental: 4 Daily Tablets Dosing	Drug: Norprolac; Quinagolide

Outcome Measures

Primary Outcome Measures

1. OHSS [41 days after hCG injection]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 37 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria

1. Signed Informed Consent Form, prior to screening evaluations

2. In good physical and mental health

3. Pre-menopausal females between the ages of 21-37 years (both inclusive) at the time of randomisation

4. Infertility for at least 1 year before randomisation, except for proven bilateral tubal infertility

Exclusion Criteria

1. Any clinically significant systemic disease

2. Endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney)

3. History of recurrent miscarriage

4. Undiagnosed vaginal bleeding

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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
5	IVI Sevilla, Avda. República Argentina, 58	Sevilla		Spain	41011
6	IVI Valencia, Plaza de la Policía Local, 3	Valencia		Spain	46015
7	IVI Vigo, Plaza Francisco Fernández del Riego, 7 (Plaza Elíptica)	Vigo (Pontevedra)		Spain	36203

Sponsors and Collaborators

• Ferring Pharmaceuticals

Investigators

• Study Director: Clinical Development Support, Ferring Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00329693
• Other Study ID Numbers: FE999051 CS01
• First Posted: May 25, 2006
• Last Update Posted: May 19, 2011
• Last Verified: May 1, 2011

• Additional relevant MeSH terms: Ovarian Hyperstimulation Syndrome; Syndrome; Quinagolide

Study Results

No Results Posted as of May 19, 2011