NCT02491437

A Study Comparing the Efficacy, Safety and Tolerability of Oral Dydrogesterone 30 mg Daily Versus Crinone 8% Intravaginal Progesterone Gel 90 mg Daily for Luteal Support in In-Vitro Fertilization (LOTUS II)

A Randomized, Open-label, Two-arm, Multicenter Study Comparing the Efficacy, Safety and Tolerability of Oral Dydrogesterone 30 mg Daily Versus Crinone 8% Intravaginal Progesterone Gel 90 mg Daily for Luteal Support in In-Vitro Fertilization (LOTUS II)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,034 (actual)
• Sponsor: Abbott · Industry
• Sex: Female
• Age: 19 Years – 41 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this randomized, two-arm and open label study is to demonstrate that the treatment of a daily dose of 3x10mg dydrogesterone orally is as effective and safe as the daily dose Crinone 8% intravaginal progesterone gel 90 mg for the luteal support in women who are unable to conceive a child and are 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 during treatment until 30 days after delivery to record any safety and tolerability data of the patient and their newborn (s).

Detailed description

"This article has been accepted for publication in Human Reproduction published by Oxford University Press."

Conditions

• Female Infertility

Interventions

Type	Name	Description
DRUG	Dydrogesterone 30 mg	Oral Dydrogesterone 10 mg tablets tid
DRUG	intravaginal progesterone gel 90 mg

Timeline

• Start date: 2015-07-01
• Primary completion: 2017-05-01
• Completion: 2017-05-01
• First posted: 2015-07-08
• Last updated: 2019-10-01
• Results posted: 2019-10-01

Locations

40 sites across 10 countries: Australia, Belgium, China, Germany, Hong Kong, India, Russia, Singapore, Thailand, Ukraine