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Progesterone in Luteal Phase Deficiency

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ClinicalTrials.gov Identifier: NCT02950948
Recruitment Status : Withdrawn (inability to recruit an adequate number of subjects.)
First Posted : November 1, 2016
Last Update Posted : December 6, 2017
Sponsor:
Information provided by (Responsible Party):
IBSA Institut Biochimique SA

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
Luteal Phase Defect Drug: Progesterone Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
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
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Control




Primary Outcome Measures :
  1. Ongoing pregnancy rate at 12 weeks of gestation [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Rate of in phase endometrial biopsies [ Time Frame: 3 months ]
  2. Length of luteal phase [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

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Responsible Party: IBSA Institut Biochimique SA
ClinicalTrials.gov Identifier: NCT02950948     History of Changes
Other Study ID Numbers: 16I-Prg05
First Posted: November 1, 2016    Key Record Dates
Last Update Posted: December 6, 2017
Last Verified: December 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs