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.

Phase 1

Conditions: Women with diagnosis of luteal phase deficiency.
MedDRA version: 20.0Level: PTClassification code 10063291Term: ProgesteroneSystem Organ Class: 10022891 - Investigations
MedDRA version: 20.0Level: PTClassification code 10036562Term: Pregnancy in habitual aborterSystem Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions
Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

Registration Number: EUCTR2016-002731-14-IT

Lead Sponsor: IBSA INSTITUT BIOCHIMIQUE SA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 60

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;
-Menstrual period shorter than 25 days;
-Sub-fertile couple: 12 months of trying to conceive without success;
-Basal P4 level (day 3 of a previous cycle) = 1.5 ng/ml;
-Fertile male partner (normal sperm count);
-Inadequate luteal phase (period between LH peak and onset of menstruation shorter than 9 days).

Are the trial subjects under 18? no
Number of subjects for this age range: 1
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-History of recurrent miscarriage;
-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 stage III or IV;
-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.