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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

182 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2008-05-31

Brief Summary

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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.

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Detailed Description

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No data to be entered.

Conditions

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Ovarian Hyperstimulation Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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1

Daily Tablets Dosing

Group Type PLACEBO_COMPARATOR

Norprolac

Intervention Type DRUG

Placebo

2

Daily Tablets Dose

Group Type EXPERIMENTAL

Norprolac

Intervention Type DRUG

Quinagolide

3

Daily Tablets Dosing

Group Type EXPERIMENTAL

Norprolac

Intervention Type DRUG

Quinagolide

4

Daily Tablets Dosing

Group Type EXPERIMENTAL

Norprolac

Intervention Type DRUG

Quinagolide

Interventions

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Norprolac

Placebo

Intervention Type DRUG

Norprolac

Quinagolide

Intervention Type DRUG

Norprolac

Quinagolide

Intervention Type DRUG

Norprolac

Quinagolide

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

37 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No