Subcutaneous Progesterone Supplementation in Patients With Endometriosis (PleyrisEndom)

November 17, 2016 updated by: Fulvio Zullo, University Magna Graecia

The Role of the Subcutaneous Progesterone in Luteal Phase Supplementation in Patients With Endometriosis

The aim of the study protocol will be to compare the efficacy of subcutaneous progesterone (25 mg / day; Pleyris, IBSA Institut Biochimique SA) with vaginal progesterone (90 mg / day; Crinone, Merck Serono) administered during the luteal phase in term of pelvic pain reduction in patients with grade I-II endometriosis and / or endometrioma <4 cm subjected to time intercourses or COS/IUI cycles.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Patients with grade I-II endometriosis and / or endometrioma <4 cm subjected to time intercourses or COS/IUI cycles will be subjected to subcutaneous or vaginal progesterone for their luteal phase supplementation in time intercourses or IUI cycles.

The aim of the study protocol will be to compare the efficacy of subcutaneous progesterone (25 mg / day; Pleyris, IBSA Institut Biochimique SA) with vaginal progesterone (90 mg / day; Crinone, Merck Serono) administered during the luteal phase in term of pelvic pain reduction

Study Type

Interventional

Enrollment (Anticipated)

52

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • CZ
      • Catanzaro, CZ, Italy, 88100
        • Recruiting
        • Magna Graecia University - Azienda Ospedaliera Pugliese Ciaccio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Laparoscopic or ultrasonographic diagnosis of endometriosis grade I-II and / or endometrioma <4 cm;
  • Menstrual VAS score> 5 cm before the last menstrual period with progesterone treatment
  • Infertility for at least 1 year
  • Body Mass Index 19 to 30 kg / m2
  • Basal FSH serum <15 IU / ml
  • Normal levels of serum prolactin
  • Normal uterine cavity and fallopian patency

Exclusion Criteria:

  • Previous ovarian surgery
  • Endocrine disorders (eg polycystic ovary syndrome, thyroid disease, hyperprolactinemia, hypogonadotropic hypogonadism)
  • Reduced ovarian reserve (basal levels of FSH> 15 IU / mL)
  • Acute or chronic infectious state
  • Chronic drug intake, alcohol, or drugs that affect cognitive functions, alertness and / or mood
  • Psychiatric disorders
  • Kidney or liver diseases
  • Male factor infertility

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pleyris
Subcutaneous progesterone will be administered 25 mg a day from the day following the ovulation for 14 days
Drug: Pleyris
Luteal phase will be supplemented starting by the ovulation day for 14 days
Other Names:
  • Subcutaneous progesterone
Active Comparator: Crinone8
Vaginal progesterone will be administered 90 mg a day from the day following the ovulation for 14 days
Drug: Crinone8
Luteal phase will be supplemented starting by the ovulation day for 14 days
Other Names:
  • vaginal progesterone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Delta VAS pain
Time Frame: 7 days after the end of the menstrual period subsequent to the luteal supplementation
Patients will be asked to score their menstrual pain using a VAS scale
7 days after the end of the menstrual period subsequent to the luteal supplementation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analgesic use
Time Frame: 7 days after the end of the menstrual period subsequent to the luteal supplementation
Patients will be asked how many vials of analgesics they needed during their menstrual period
7 days after the end of the menstrual period subsequent to the luteal supplementation
Pregnancy rate
Time Frame: 30 days after the end of the menstrual period subsequent to the luteal supplementation
The percentage of pregnancies achieved in both arms will be assessed
30 days after the end of the menstrual period subsequent to the luteal supplementation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Magna Graecia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Anticipated)

June 1, 2017

Study Completion (Anticipated)

August 1, 2017

Study Registration Dates

First Submitted

June 2, 2016

First Submitted That Met QC Criteria

June 7, 2016

First Posted (Estimate)

June 8, 2016

Study Record Updates

Last Update Posted (Estimate)

November 21, 2016

Last Update Submitted That Met QC Criteria

November 17, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMagnaGraecia

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Data will be published at the end of the study.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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