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Dydrogesterone Versus Intravaginal Progesterone in the Luteal Phase Support

NCT01178931 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 853

Last updated 2014-01-29

No results posted yet for this study

Summary

The purpose of this study is to compare efficacy and tolerability of the dydrogesterone and the vaginal progesterone, used for luteal phase support.

(Initial start date was January 2009 but not for patients' recruitment only for paper work, documents, team organization, statistical pre-work actions and to gain the official approval of Institutional Review Board. The recruitment started in October 2010 and continued until October 2013.)

Conditions

  • Luteal Phase Defect

Interventions

DRUG

Oral dydrogesterone

oral-2x10mg

DRUG

Crinone 8% gel

vaginal-1x90mg

Sponsors & Collaborators

  • University of Zagreb

    lead OTHER

Principal Investigators

  • Jozo Tomic, M.D. · Department of Human Reproduction, University Hospital Center Sisters of Mercy

  • Vlatka Tomic, M.D. · Department of Human Reproduction, University Hospital Center Sisters of Mercy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2013-10-31
Completion
2013-12-31

Countries

  • Croatia

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 NCT01178931 on ClinicalTrials.gov