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Myo-inositol Versus Clomiphene Citrate in PCOS

NCT04306692 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2022-12-21

No results posted yet for this study

Summary

Specific aim: To compare inositol and the golden standard first line treatment of ovulation induction, namely clomiphene citrate.

Conditions

  • Ovulation Induction
  • Polycystic Ovary Syndrome
  • Clomiphene
  • Inositol

Interventions

DRUG

Myo-inositol

2 x 1 bag per day, per os (subjects can take myo-inositol during the meal but it is not obliged).

DRUG

Clomiphene Citrate

Each tablet contains 50 mg of clomiphene citrate which means 33,9 mg of clomiphene. Other constituents are sucrose, lactose monohydrate, corn starch, pregelatinized starch, yellow iron oxide (E172) and magnesium stearate (E470b). Dosing: 1 tablet per day from cycle day 3 until 7 (extremes included), stepping up until a maximum dose of 3 tablets per day for 5 consecutive days.

Sponsors & Collaborators

  • Gedeon Richter Plc.

    collaborator INDUSTRY

  • University Hospital, Antwerp

    collaborator OTHER

  • AZ Jan Palfijn Gent

    collaborator OTHER

  • Our Lady of Lourdes Hospital Waregem

    collaborator UNKNOWN

  • University Hospital, Ghent

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-02
Primary Completion
2021-04-20
Completion
2022-01-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04306692 on ClinicalTrials.gov