Progesterone in Luteal Phase Deficiency

Luteal Phase Defect Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02950948
• Other study ID #: 16I-Prg05
• Status: Withdrawn
• Phase: Phase 3
• First received: October 27, 2016
• Last updated: December 5, 2017
• Start date: May 3, 2017
• Est. completion date: December 2019

Study information

• Verified date: December 2017
• Source: IBSA Institut Biochimique SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Luteal Phase Defect

Intervention

Drug:
• Progesterone
Progesterone will be administered subcutaneously once a day for 14 days/month, for 12 months.
• Placebo
A placebo solution will be administered subcutaneously once a day for 14 days/month, for 12 months.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
IBSA Institut Biochimique SA

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ongoing pregnancy rate at 12 weeks of gestation		12 weeks
Secondary	Rate of in phase endometrial biopsies		3 months
Secondary	Length of luteal phase		3 months