NCT01850030

A Multicenter Study Comparing the Efficacy, Safety and Tolerability of Oral Dydrogesterone 30 mg Daily Versus Intravaginal Micronized Progesterone Capsules 600 mg Daily for Luteal Support in In-Vitro Fertilization

A Double-Blind, Double-Dummy, Randomized, Two-arm, Multicenter Study Comparing the Efficacy, Safety and Tolerability of Oral Dydrogesterone 30 mg Daily Versus Intravaginal Micronized Progesterone Capsules 600 mg Daily for Luteal Support in In-Vitro Fertilization (Lotus I)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,070 (actual)
• Sponsor: Abbott · Industry
• Sex: Female
• Age: 19 Years – 41 Years
• Healthy volunteers: Not accepted

Summary

Female inability to conceive a child. The purpose of this randomized, two-arm and double blind, double dummy study is to demonstrate that the treatment of a daily dose of 3x10mg dydrogesterone orally is as effective and safe as the daily dose of 3x200 mg micronized progesterone capsules administered intravaginally for the luteal support in patients undergoing IVF. The treatment will start on the day of oocyte retrieval and continue until pregnancy is negative or until week 12 gestation.Patients will be followed after treatment until 30 days after delivery to record any safety and tolerability data of the patient and their newborn(s).

Conditions

• Female Infertility

Interventions

Type	Name	Description
DRUG	Dydrogesterone 30 mg	Oral Dydrogesterone 10 mg tablets tid
DRUG	Micronized Progesterone 600 mg	Intravaginal micronized progesterone 200 mg capsules tid
DRUG	Placebo progesterone	Placebo intravaginal micronized progesterone 200 mg capsules tid
DRUG	Placebo dydrogesterone	placebo oral dydrogesterone 10 mg tablets tid

Timeline

• Start date: 2013-08-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2013-05-09
• Last updated: 2018-01-02
• Results posted: 2018-01-02

Locations

40 sites across 7 countries: Austria, Belgium, Finland, Germany, Israel, Russia, Spain