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 个研究点目标入组 60 人开始时间: 2018年2月27日最近更新: 2018年3月5日

试验速览

暂无简介。

•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

•-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;
•-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;

发起方