Progesterone in Luteal Phase Deficiency

Prospective, Randomised, Double-blind, Placebo Controlled, Phase III Clinical Study Assessing the Efficacy of 25 mg Natural Progesterone Administered Subcutaneously in Restoring the Normal Luteal Phase in Women With Previous Diagnosis of Luteal Phase Deficiency

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).

Study Overview

• Status: Withdrawn
• Conditions: Luteal Phase Defect
• Intervention / Treatment: Drug: Progesterone; Drug: Placebo

• Study Type: Interventional
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 33 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Women who wish to get pregnant with a previous diagnosis of luteal phase deficiency:
• Able and willing to sign the Subject Consent Form and adhere to the study visit schedule;
• Age: 20-35 years;
• BMI: 18-28 kg/m2;
• Inadequate luteal phase (menstrual period shorter than 21 days);
• Sub-fertile couple: 12 months of trying to conceive without success.
• Normal uterine cavity;
• Basal P4 level (day 3 of a previous cycle) ≤ 3ng/ml;
• Non-smoking;
• Fertile male partner (normal sperm count).

Exclusion Criteria:

• History of recurrent miscarriage;
• Basal P4 level (day 3 of a previous cycle) > 3ng/ml;
• Severe uterine malformations (including submucosal fibroids, endometrial polyps, and intrauterine adhesions) ;
• Known hypersensitivity to study medication;
• Neoplasias (known or suspected breast or genital tract cancer);
• Severe impairment of hepatic or renal function;
• Use of concomitant medications that might interfere with study evaluations (other hormonal treatment);
• Current vaginal infection;
• Endometriosis;
• PCOS;
• Partially or completed block of fallopian tubes;
• Hydrosalpinx;
• Active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events;
• Porphyria;
• A history of idiopathic jaundice, severe pruritus or pemphigoid gestationis during pregnancy;
• Antiphospholipid syndrome;
• Diabetes mellitus;
• Thyroid diseases or autoimmune conditions;
• Hypothalamic dysfunction;
• Hyperprolactinaemia;
• Infertility due to male factor;
• Smokers.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Progesterone; 25 mg of progesterone will be administered daily by subcutaneous injection.	Drug: Progesterone; Progesterone will be administered subcutaneously once a day for 14 days/month, for 12 months.; Other Names: Test
Placebo Comparator: Placebo; 25 mg of progesterone will be administered daily by subcutaneous injection.	Drug: Placebo; A placebo solution will be administered subcutaneously once a day for 14 days/month, for 12 months.; Other Names: Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Ongoing pregnancy rate at 12 weeks of gestation	12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Rate of in phase endometrial biopsies	3 months
Length of luteal phase	3 months

Collaborators and Investigators

• Sponsor: IBSA Institut Biochimique SA

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2017
• Primary Completion (Anticipated): March 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: October 27, 2016
• First Submitted That Met QC Criteria: October 31, 2016
• First Posted (Estimate): November 1, 2016

Study Record Updates

• Last Update Posted (Actual): December 6, 2017
• Last Update Submitted That Met QC Criteria: December 5, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progestins; Progesterone
• Other Study ID Numbers: 16I-Prg05

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No