Habitual Abortion Study: Oral Dydrogesterone Treatment During Pregnancy in Women With Recurrent Miscarriage - Tabular View

Tracking Information

First Received Date ^ICMJE

September 11, 2005

Last Updated Date

September 24, 2009

Start Date ^ICMJE

September 2003

Primary Completion Date

September 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Cytokine ratio IFN/IL-10 [ Time Frame: 14 weeks treatment after diagnosed pregnancy (week of gestation 4 to 18) ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

the ratio IFN/IL-10

Change History

Complete list of historical versions of study NCT00193674 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Exploratory analysis of pregnancy outcome by monitoring biochemical and clinical pregnancy parameters, weekly evaluation of serum progesterone [ Time Frame: first trimester of pregnancy ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

biochemical and clinical pregnancy parameters, prevention of spontaneous miscarriage among women with a history of idiopathic recurrent miscarriage.

Descriptive Information

Brief Title ^ICMJE

Habitual Abortion Study: Oral Dydrogesterone Treatment During Pregnancy in Women With Recurrent Miscarriage

Official Title ^ICMJE

Oral Dydrogesterone Treatment During the First Trimester of Pregnancy in Women With Recurrent Miscarriage: A Double-Blind, Prospectively Randomized, Placebo-Controlled, Parallel Group Trial

Brief Summary

The purpose of this clinical study is to demonstrate the shift from inflammatory cytokines to non-inflammatory cytokines in women suffering from habitual abortion treated with dydrogesterone (Duphaston).

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Pharmacodynamics Study

Condition ^ICMJE

Recurrent Miscarriage

Intervention ^ICMJE

Drug: Dydrogesterone
Drug: Placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

September 2009

Primary Completion Date

September 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Women with a history of idiopathic recurrent miscarriage, based on a documented history of at least three spontaneous consecutive miscarriages before 20 weeks gestation with the same partner

Exclusion Criteria:

Any verifiable cause of the recurrent miscarriages apart from luteal phase defect (e.g. systemic lupus erythematosus [SLE], infections with chlamydia or mycoplasma)
Any gynecological neoplasias or anatomical abnormalities that oppose pregnancy
Concurrent infertility treatment/superovulation protocol

Gender

Female

Ages

18 Years to 38 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Austria, Poland

Administrative Information

NCT ID ^ICMJE

NCT00193674

Responsible Party

Gregor Eibes, Solvay Pharmaceuticals

Study ID Numbers ^ICMJE

S102.3.116

Study Sponsor ^ICMJE

Solvay Pharmaceuticals

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Global Clinical Director Solvay

Solvay Pharmaceuticals

Information Provided By

Solvay Pharmaceuticals

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP