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

This study has been completed.

First Received on September 11, 2005. Last Updated on August 25, 2011 History of Changes

Sponsor:	Abbott Products
Information provided by (Responsible Party):	Abbott ( Abbott Products )
ClinicalTrials.gov Identifier:	NCT00193674

Purpose

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).

Condition	Intervention	Phase
Recurrent Miscarriage	Drug: Dydrogesterone Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Oral Dydrogesterone Treatment During the First Trimester of Pregnancy in Women With Recurrent Miscarriage: A Double-Blind, Prospectively Randomized, Placebo-Controlled, Parallel Group Trial

Resource links provided by NLM:

MedlinePlus related topics: Miscarriage

Drug Information available for: Dydrogesterone

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Enrollment:	71
Study Start Date:	September 2003
Study Completion Date:	July 2009
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: Dydrogesterone 20 mg/day, oral
Placebo Comparator: 2	Drug: Placebo Placebo

Eligibility

Ages Eligible for Study:	18 Years to 38 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00193674

Locations

Austria
Site Reference ID/Investigator# 61182
Vienna, Austria, 1090
Poland
Site Reference ID/Investigator# 61183
Poznan, Poland, 60-535
Site Reference ID/Investigator# 61184
Szczecin, Poland, 72-010

Sponsors and Collaborators

Abbott Products

Investigators

Study Director:

Guenter Krause, MD

Abbott Products

More Information

No publications provided

Responsible Party:	Abbott ( Abbott Products )
ClinicalTrials.gov Identifier:	NCT00193674 History of Changes
Other Study ID Numbers:	S102.3.116
Study First Received:	September 11, 2005
Last Updated:	August 25, 2011
Health Authority:	Austria: Federal Ministry for Health and Women; Poland: Ministry of Health

Keywords provided by Abbott:

Pregnancy
Immunology
Unexplained recurrent miscarriage

Additional relevant MeSH terms:

Abortion, Spontaneous
Abortion, Missed
Abortion, Threatened
Abortion, Habitual
Pregnancy Complications
Dydrogesterone

Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012