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

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Abbott

Status and phase

Completed
Phase 3

Conditions

Recurrent Miscarriage

Treatments

Drug: Placebo
Drug: Dydrogesterone

Study type

Interventional

Funder types

Industry

Identifiers

NCT00193674
S102.3.116

Details and patient eligibility

About

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).

Enrollment

71 patients

Sex

Female

Ages

18 to 38 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

71 participants in 2 patient groups, including a placebo group

1
Experimental group
Treatment:
Drug: Dydrogesterone
2
Placebo Comparator group
Treatment:
Drug: Placebo

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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