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. - Progesterone (Pleyris)

IBSA INSTITUT BIOCHIMIQUE SA0 sites60 target enrollmentFebruary 27, 2018

Overview

No summary available.

Registry

who.int

Start Date

February 27, 2018

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

•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

•\-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;
•\-Partially or completed block of fallopian tubes;
•\-Hydrosalpinx;