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.

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)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002731-14-IT

Enrollment

Registered

2018-02-27

Start date

2017-02-20

Completion date

Unknown

Last updated

2018-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Women with diagnosis of luteal phase deficiency. MedDRA version: 20.0 Level: PT Classification code 10063291 Term: Progesterone System Organ Class: 10022891 - Investigations MedDRA version: 20.0 Level: PT Classification code 10036562 Term: Pregnancy in habitual aborter System Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions

Interventions

Trade Name: PLEYRIS - 25 MG/ML SOLUZIONE INIETTABILE 1 FLACONCINO IN VETRO Pharmaceutical Form: Suspension for injection INN or Proposed INN: PROGESTERONE Current Sponsor code: IBSA Other descriptive

Eligibility

Sex/Gender

All

Inclusion 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; - 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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: 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.;Secondary Objective: 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). ;Primary end point(s): Ongoing pregnancy rate at 12 weeks of gestation;Timepoint(s) of evaluation of this end point: 12 weeks	—

Measure

Time frame

Main Objective: 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.;Secondary Objective: 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). ;Primary end point(s): Ongoing pregnancy rate at 12 weeks of gestation;Timepoint(s) of evaluation of this end point: 12 weeks

—

Secondary

Measure	Time frame
Secondary end point(s): Rate of in phase endometrial biopsies 3 months after treatment start. Biopsies will be evaluated morphologically (according to Noyes criteria) with light microscopy and the presence of pinopodes will be further investigated with electron microscopy. Length of luteal phase (from LH peak to onset of menstruation). ;Timepoint(s) of evaluation of this end point: Three months	—

Countries

Italy

Contacts

Public ContactClinical Operations

PharmaD&S

edimartino@pharmades.it055 7224179

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026