For Healthcare Professionals

A Multi-center, Placebo-controlled Study to Evaluate NT100 in Pregnant Women With a History of Unexplained Recurrent Pregnancy Loss (RPL)

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About the study

This is a randomised, double blind, multi-center, placebo-controlled study of subcutaneous NT100 in pregnant women with a history of unexplained recurrent pregnancy loss. Approximately 150 participants will be randomised to receive subcutaneous NT100 or placebo.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

  1. Pre-menopausal female 18-37 years of age at consent, trying to conceive
  2. Documented history of unexplained recurrent pregnancy loss
  3. Spontaneous conception, as confirmed by urine pregnancy test performed at the investigative site
  4. Body mass index (BMI) of 19-35 kg/m2 at consent

EXCLUSION CRITERIA

  1. Greater than 5 weeks of gestation when presenting for randomisation.
  2. Known karyotype abnormalities in either the participant or her current male partner
  3. Uncorrected clinically significant intrauterine abnormalities
  4. Abnormal vaginal bleeding of unknown cause
  5. Current diagnosis of infertility in either the participant or her current male partner
  6. Current or past diagnosis of systemic autoimmune disease, coagulopathy, hyperprolactinemia, cervical incompetence, or high-grade cervical dysplasia with conization/surgery.
  7. Any uncontrolled clinically significant medical condition
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall +1-650-353-5520Email iconEmail Study Center

Study’s details


Contition

Recurrent Miscarriage,Recurrent Pregnancy Loss

Age (in years)

18 - 37

Phase

Phase 2

Participants needed

150

Est. Completion Date

Jun 2016

Treatment type

Interventional


Sponsor

Nora Therapeutics, Inc.

ClinicalTrials.gov identifier

NCT02156063

Study number

NT-05

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