Progesterone in Luteal Phase Deficiency

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Luteal Phase Defect

Intervention / Treatment
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* Drug: Progesterone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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