Síndrome de hiperestimulación ovárica en mujeres con hiperestimulación ovárica controlada en técnicas de reproducción asistida MedDRA version: 8.1 Level: PT Classification code 10033266
Conditions
Interventions
Trade Name: Norprolac
Product Name: Norprolac
Pharmaceutical Form: Tablet
INN or Proposed INN: quinagolide
CAS Number: 87056-78-8
Current Sponsor code: FE 999051
Concentration unit: µg microgram(s)
Co
Sponsors
Ferring Pharmaceuticals A/S
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To identify the effective doses of quinagolide, including the lowest effective dose, compared to placebo in preventing moderate/severe early ovarian hyperstimulation syndrome (OHSS) ;Secondary Objective: (please note: abbreviated du to limitation in characters - see protocol section 2.1) •To estimate the dose-response in preventing moderate/severe early OHSS •To estimate the effects in reduction of the incidence of ascites, peritoneal fluid accumulation and on the frequency of subjects requiring ascitic drainage •To estimate the effects on the proportion of subjects hospitalised or restricted to bed rest because of OHSS, on the duration of hospitalisation and bed rest •To estimate the effects on the frequency of individual signs/symptoms and presentation pattern of moderate/severe OHSS •To estimate the effects on body measurements •To estimate the effects in preventing moderate/severe late OHSS •To estimate the effects on clinical pregnancy rate •To establish the safety profile ;Primary end point(s): Presence of moderate/severe early OHSS (onset = 9 days after hCG administration) | — |
Countries
Spain
Outcome results
None listed