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Progesterone in Luteal Phase Deficiency

NCT02950948 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2017-12-06

No results posted yet for this study

Summary

The main objective of this study will be to assess the efficacy of natural progesterone at a daily dose of 25 mg in restoring a normal luteal phase. The primary end-point will be the ongoing pregnancy rate.

The secondary objectives will be the rate of endometrial biopsy showing an in phase endometrium after 3 months of treatment.

The length of the luteal phase of the menstrual cycle after treatment will also be assessed and compared with the initial duration (from LH peak to onset of menstruation).

Conditions

  • Luteal Phase Defect

Interventions

DRUG

Progesterone

Progesterone will be administered subcutaneously once a day for 14 days/month, for 12 months.

DRUG

Placebo

A placebo solution will be administered subcutaneously once a day for 14 days/month, for 12 months.

Sponsors & Collaborators

  • IBSA Institut Biochimique SA

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-03
Primary Completion
2019-03-31
Completion
2019-12-31

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Drugs

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 NCT02950948 on ClinicalTrials.gov