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

This study is ongoing, but not recruiting participants.

First Received: September 11, 2005 Last Updated: May 8, 2009 History of Changes

Sponsored by:	Solvay Pharmaceuticals
Information provided by:	Solvay Pharmaceuticals
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:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Pharmacodynamics Study
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: Pregnancy Loss

Drug Information available for: Dydrogesterone

U.S. FDA Resources

Further study details as provided by Solvay Pharmaceuticals:

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:	77
Study Start Date:	September 2003
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Dydrogesterone 20 mg/day, oral
2: Placebo Comparator	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 1
Vienna, Austria
Poland
Site 2
Poznan, Poland
Site 3
Police, Poland

Sponsors and Collaborators

Solvay Pharmaceuticals

Investigators

Study Director:

Global Clinical Director Solvay

Solvay Pharmaceuticals

More Information

No publications provided

Responsible Party:	Solvay Pharmaceuticals ( Gregor Eibes )
Study ID Numbers:	S102.3.116
Study First Received:	September 11, 2005
Last Updated:	May 8, 2009
ClinicalTrials.gov Identifier:	NCT00193674 History of Changes
Health Authority:	Austria: Federal Ministry for Health and Women; Poland: Ministry of Health

Keywords provided by Solvay Pharmaceuticals:

pregnancy, immunology
unexplained recurrent miscarriage

Study placed in the following topic categories:

Dydrogesterone
Pregnancy Complications
Hormone Antagonists
Progestins
Abortion, Habitual

Hormones, Hormone Substitutes, and Hormone Antagonists
Abortion, Spontaneous
Hormones
Recurrence

Additional relevant MeSH terms:

Dydrogesterone
Disease Attributes
Pathologic Processes
Pregnancy Complications
Progestins
Physiological Effects of Drugs

Abortion, Habitual
Hormones, Hormone Substitutes, and Hormone Antagonists
Abortion, Spontaneous
Hormones
Pharmacologic Actions
Recurrence

ClinicalTrials.gov processed this record on July 02, 2009