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Subcutaneous Progesterone Supplementation in Patients With Endometriosis (PleyrisEndom)

Primary Purpose

Endometriosis

Status
Unknown status
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Pleyris
Crinone8
Sponsored by
University Magna Graecia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometriosis focused on measuring Endometriosis, Subcutaneous progesterone, luteal phase

Eligibility Criteria

18 Years - 38 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Magna Graecia University - Azienda Ospedaliera Pugliese CiaccioRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pleyris

Crinone8

Arm Description

Subcutaneous progesterone will be administered 25 mg a day from the day following the ovulation for 14 days

Vaginal progesterone will be administered 90 mg a day from the day following the ovulation for 14 days

Outcomes

Primary Outcome Measures

Delta VAS pain
Patients will be asked to score their menstrual pain using a VAS scale

Secondary Outcome Measures

Analgesic use
Patients will be asked how many vials of analgesics they needed during their menstrual period
Pregnancy rate
The percentage of pregnancies achieved in both arms will be assessed

Full Information

First Posted
June 2, 2016
Last Updated
November 17, 2016
Sponsor
University Magna Graecia
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1. Study Identification

Unique Protocol Identification Number
NCT02793908
Brief Title
Subcutaneous Progesterone Supplementation in Patients With Endometriosis
Acronym
PleyrisEndom
Official Title
The Role of the Subcutaneous Progesterone in Luteal Phase Supplementation in Patients With Endometriosis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
August 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Magna Graecia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis
Keywords
Endometriosis, Subcutaneous progesterone, luteal phase

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pleyris
Arm Type
Experimental
Arm Description
Subcutaneous progesterone will be administered 25 mg a day from the day following the ovulation for 14 days
Arm Title
Crinone8
Arm Type
Active Comparator
Arm Description
Vaginal progesterone will be administered 90 mg a day from the day following the ovulation for 14 days
Intervention Type
Drug
Intervention Name(s)
Pleyris
Other Intervention Name(s)
Subcutaneous progesterone
Intervention Description
Luteal phase will be supplemented starting by the ovulation day for 14 days
Intervention Type
Drug
Intervention Name(s)
Crinone8
Other Intervention Name(s)
vaginal progesterone
Intervention Description
Luteal phase will be supplemented starting by the ovulation day for 14 days
Primary Outcome Measure Information:
Title
Delta VAS pain
Description
Patients will be asked to score their menstrual pain using a VAS scale
Time Frame
7 days after the end of the menstrual period subsequent to the luteal supplementation
Secondary Outcome Measure Information:
Title
Analgesic use
Description
Patients will be asked how many vials of analgesics they needed during their menstrual period
Time Frame
7 days after the end of the menstrual period subsequent to the luteal supplementation
Title
Pregnancy rate
Description
The percentage of pregnancies achieved in both arms will be assessed
Time Frame
30 days after the end of the menstrual period subsequent to the luteal supplementation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fulvio Zullo, MD, PhD
Phone
337947003
Email
zullo@unicz.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fulvio Zullo
Organizational Affiliation
Magna Graecia University of Catanzaro
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Roberta Venturella
Organizational Affiliation
Magna Graecia University of Catanzaro
Official's Role
Principal Investigator
Facility Information:
Facility Name
Magna Graecia University - Azienda Ospedaliera Pugliese Ciaccio
City
Catanzaro
State/Province
CZ
ZIP/Postal Code
88100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fulvio Zullo, MD, PhD
Phone
39337947003
Email
zullo@unicz.it
First Name & Middle Initial & Last Name & Degree
Roberta Venturella, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be published at the end of the study.

Learn more about this trial

Subcutaneous Progesterone Supplementation in Patients With Endometriosis

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