EQUIPO (Efecto de Quinagolida en la Prevención de OHSS)Estudio de prueba de hipótesis, aleatorizado, doble ciego, de grupos paralelos, en búsqueda de dosis, controlado con placebo, multicéntrico, para la determinación del efecto de 3 semanas de tratamiento, con una de las tres dosis orales de Quinagolida (50, 100, 200 µg/día) y placebo, para la prevención del síndrome de hiperestimulación ovárica en mujeres con hiperestimulación ovárica controlada en técnicas de reproducción asistida. - EQUIPO

Phase 1

• Conditions: Síndrome de hiperestimulación ovárica en mujeres con hiperestimulación ovárica controlada en técnicas de reproducción asistida; MedDRA version: 8.1Level: PTClassification code 10033266

• Registration Number: EUCTR2006-000415-15-ES
• Lead Sponsor: Ferring Pharmaceuticals A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-04-17
• Study Completion: 2007-08-11
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

Subjects eligible for this study are women 21-37 years of age (both inclusive), generally healthy and with BMI 18-29 kg/m2 (both inclusive) who are undergoing controlled ovarian hyperstimulation for assisted reproductive technologies and who present with a risk of developing OHSS. They must have 20-30 follicles (both inclusive) =10 mm at the time of hCG administration, but serum estradiol below 6,000 pg/mL. Eligible subjects must have been infertile for at least 1 year and willing to accept transfer of 1 or 2 embryos.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects with a history of psychotic disorder, hypotension, orthostatic hypotension or recurrent syncope, or with impaired liver or kidney function are not eligible. Also, subjects being treated for hypertension or receiving therapy with dopamine agonists, dopamine antagonists, anti-psychotics, anti-depressants, anxiolytics, hypnotics or sedatives are not eligible.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified