Progesterone in Luteal Phase Deficiency

NCT02950948 | Withdrawn Phase 3

• 1 other identifier: 16I-Prg05
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Ongoing pregnancy rate at 12 weeks of gestation

  12 weeks

Secondary Outcomes (2)

• Rate of in phase endometrial biopsies

  3 months

• Length of luteal phase

  3 months

Study Arms (2)

Progesterone

EXPERIMENTAL

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

Drug: Progesterone

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Progesterone DRUG

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

Also known as: Test

Progesterone

Placebo DRUG

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

Also known as: Control

Placebo

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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;

Sponsors & Collaborators

• IBSA Institut Biochimique SA: lead

MeSH Terms

Interventions

Progesterone

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2016
• First Posted: November 1, 2016
• Study Start: May 3, 2017
• Primary Completion: March 1, 2019
• Study Completion: December 1, 2019
• Last Updated: December 6, 2017

Record last verified: 2017-12