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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)

NCT02491437 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1034

Last updated 2019-10-01

Study results available
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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).

Conditions

  • Female Infertility

Interventions

DRUG

Dydrogesterone 30 mg

Oral Dydrogesterone 10 mg tablets tid

DRUG

intravaginal progesterone gel 90 mg

Sponsors & Collaborators

  • PRA Health Sciences

    collaborator INDUSTRY

  • Datamap

    collaborator INDUSTRY

  • Abbott

    lead INDUSTRY

Principal Investigators

  • Shreyansh Shah, MD · Abbott

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
41 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2017-05-31
Completion
2017-05-31

Countries

  • Australia
  • Belgium
  • China
  • Germany
  • Hong Kong
  • India
  • Russia
  • Singapore
  • Thailand
  • Ukraine

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02491437 on ClinicalTrials.gov