At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 3 clinical trial evaluating Dydrogesterone 30 mg, Micronized Progesterone 600 mg, and 2 other interventions for Female Infertility. Completed, enrolled 1,070 participants across 40 sites in 7 countries.
Detailed 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).
Study Details
Timeline
Interventions
Oral Dydrogesterone 10 mg tablets tid
Intravaginal micronized progesterone 200 mg capsules tid
Placebo intravaginal micronized progesterone 200 mg capsules tid
placebo oral dydrogesterone 10 mg tablets tid