Progesterone in Luteal Phase Deficiency

NCT ID: NCT02950948

Last Updated: 2017-12-06

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-03
• Study Completion Date: 2019-12-31

Brief 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).

Conditions

Luteal Phase Defect

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Progesterone

25 mg of progesterone will be administered daily by subcutaneous injection.

Group Type: EXPERIMENTAL

Progesterone

Intervention Type: DRUG

Progesterone will be administered subcutaneously once a day for 14 days/month, for 12 months.

Placebo

25 mg of progesterone will be administered daily by subcutaneous injection.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

A placebo solution will be administered subcutaneously once a day for 14 days/month, for 12 months.

Interventions

Progesterone

Progesterone will be administered subcutaneously once a day for 14 days/month, for 12 months.

Intervention Type: DRUG

Placebo

A placebo solution will be administered subcutaneously once a day for 14 days/month, for 12 months.

Intervention Type: DRUG

Other Intervention Names

Test; Control

Eligibility 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;
• 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

IBSA Institut Biochimique SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

16I-Prg05

Identifier Type: -

Identifier Source: org_study_id