NCT02950935

Progesterone in Threatened Abortion

Prospective, Double-blind, Randomised, Placebo Controlled, Phase III Clinical Study Assessing the Efficacy of Natural Progesterone 25 mg/Bid Administered Subcutaneously in the Maintenance of Early Pregnancy in Women With Symptoms of Threatened Abortion

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: IBSA Institut Biochimique SA · Industry
• Sex: Female
• Age: 18 Years – 37 Years
• Healthy volunteers: Not accepted

Summary

The main objective of this study will be to assess the efficacy of natural progesterone at a daily dose of 25 mg/bid in the maintenance of early pregnancy in women with symptoms of threatened abortion. The secondary objectives will be the efficacy of progesterone in reducing both pain and uterine contractions.

Conditions

• Threatened Abortion in First Trimester

Interventions

Type	Name	Description
DRUG	Progesterone	subcutaneous injection of progesterone solution will be performed twice à day from onset of threatened abortion symptoms until week 12 of pregnancy.
DRUG	Placebo	subcutaneous injection of placebo solution will be performed twice à day from onset of threatened abortion symptoms until week 12 of pregnancy.

Timeline

• Start date: 2017-04-04
• Primary completion: 2018-05-02
• Completion: 2018-05-02
• First posted: 2016-11-01
• Last updated: 2018-07-20

Locations

4 sites across 1 country: Italy