NCT00193674

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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2003

Longer than P75 for phase_3

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

August 26, 2011

Status Verified

August 1, 2011

Enrollment Period

5.8 years

First QC Date

September 11, 2005

Last Update Submit

August 25, 2011

Conditions

Recurrent Miscarriage

Keywords

PregnancyImmunologyUnexplained recurrent miscarriage

Outcome Measures

Primary Outcomes (1)

  • Cytokine ratio IFN/IL-10

    14 weeks treatment after diagnosed pregnancy (week of gestation 4 to 18)

Secondary Outcomes (1)

  • Exploratory analysis of pregnancy outcome by monitoring biochemical and clinical pregnancy parameters, weekly evaluation of serum progesterone

    First trimester of pregnancy

Study Arms (2)

1

EXPERIMENTAL
Drug: Dydrogesterone

2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

DydrogesteroneDRUG

20 mg/day, oral

1
PlaceboDRUG

Placebo

2

Eligibility Criteria

Age18 Years - 38 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Site Reference ID/Investigator# 61182

Vienna, 1090, Austria

Location

Site Reference ID/Investigator# 61183

Poznan, 60-535, Poland

Location

Site Reference ID/Investigator# 61184

Szczecin, 72-010, Poland

Location

MeSH Terms

Conditions

Abortion, Habitual

Interventions

Dydrogesterone

Condition Hierarchy (Ancestors)

Abortion, SpontaneousPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

PregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Guenter Krause, MD

    Abbott Products

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2005

First Posted

September 19, 2005

Study Start

September 1, 2003

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

August 26, 2011

Record last verified: 2011-08

Locations

PL(2)AU(1)