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

NCT ID: NCT00193674

Last Updated: 2011-08-26

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

PHASE3

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2009-07-31

Brief Summary

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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

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Conditions

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Recurrent Miscarriage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

Dydrogesterone

Intervention Type DRUG

20 mg/day, oral

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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Dydrogesterone

20 mg/day, oral

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Abbott Products

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guenter Krause, MD

Role: STUDY_DIRECTOR

Abbott Products

Locations

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Site Reference ID/Investigator# 61182

Vienna, , Austria

Site Status

Site Reference ID/Investigator# 61183

Poznan, , Poland

Site Status

Site Reference ID/Investigator# 61184

Szczecin, , Poland

Site Status

Countries

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Austria Poland

Other Identifiers

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S102.3.116

Identifier Type: -

Identifier Source: org_study_id

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