Habitual Abortion Study: Oral Dydrogesterone Treatment During Pregnancy in Women With Recurrent Miscarriage
This study has been completed.
Sponsor:
Abbott Products
Information provided by (Responsible Party):
Abbott ( Abbott Products )
ClinicalTrials.gov Identifier:
NCT00193674
First received: September 11, 2005
Last updated: August 25, 2011
Last verified: August 2011
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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 3 |
| 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:
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, Habitual Pregnancy Complications Dydrogesterone Progestins |
Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013