UnknownPhase 2

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

United Kingdom150 participantsStarted 2014-06

Plain-language summary

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.

Who can participate

Age range18 Years – 37 Years

SexFEMALE

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Inclusion criteria

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

Exclusion criteria

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

What they're measuring

Clinical Pregnancy

Timeframe: at Week 20 of gestation

Trial details

NCT IDNCT02156063

SponsorNora Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-01

View on ClinicalTrials.gov More Recurrent Pregnancy Loss trials