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Progesterone in Luteal Phase Deficiency

Sponsor
IBSA Institut Biochimique SA (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT02950948
Collaborator
(none)
0
Enrollment
2
Arms
30.9
Anticipated Duration (Months)

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
May 3, 2017
Anticipated Primary Completion Date :
Mar 1, 2019
Anticipated Study Completion Date :
Dec 1, 2019

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Ongoing pregnancy rate at 12 weeks of gestation [12 weeks]

    Secondary Outcome Measures

    1. Rate of in phase endometrial biopsies [3 months]

    2. Length of luteal phase [3 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 35 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • IBSA Institut Biochimique SA

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    IBSA Institut Biochimique SA
    ClinicalTrials.gov Identifier:
    NCT02950948
    Other Study ID Numbers:
    • 16I-Prg05
    First Posted:
    Nov 1, 2016
    Last Update Posted:
    Dec 6, 2017
    Last Verified:
    Dec 1, 2017
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Progesterone

    Study Results

    No Results Posted as of Dec 6, 2017