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

Ferring

Status and phase: Completed; Phase 2

Conditions: Ovarian Hyperstimulation Syndrome

Treatments: Drug: Norprolac

Study type: Interventional

Funder types: Industry

Identifiers

NCT00329693

FE999051 CS01

Details and patient eligibility

About

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.

Full description

No data to be entered.

Enrollment: 182 patients

Sex: Female

Ages: 21 to 37 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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182 participants in 4 patient groups, including a placebo group

1

Placebo Comparator group

Description:

Daily Tablets Dosing

Treatment:

Drug: Norprolac

Drug: Norprolac

Drug: Norprolac

Drug: Norprolac

2

Experimental group

Description:

Daily Tablets Dose

Treatment:

Drug: Norprolac

Drug: Norprolac

Drug: Norprolac

Drug: Norprolac

3

Experimental group

Description:

Daily Tablets Dosing

Treatment:

Drug: Norprolac

Drug: Norprolac

Drug: Norprolac

Drug: Norprolac

4

Experimental group

Description:

Daily Tablets Dosing

Treatment:

Drug: Norprolac

Drug: Norprolac

Drug: Norprolac

Drug: Norprolac