Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Subcutaneous Progesterone Supplementation in Patients With Endometriosis (PleyrisEndom)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02793908
Recruitment Status : Unknown
Verified November 2016 by Fulvio Zullo, University Magna Graecia.
Recruitment status was:  Recruiting
First Posted : June 8, 2016
Last Update Posted : November 21, 2016
Sponsor:
Information provided by (Responsible Party):
Fulvio Zullo, University Magna Graecia

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.

Condition or disease Intervention/treatment Phase
Endometriosis Drug: Pleyris Drug: Crinone8 Phase 3

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


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Role of the Subcutaneous Progesterone in Luteal Phase Supplementation in Patients With Endometriosis
Study Start Date : June 2016
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

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 Name: 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 Name: vaginal progesterone




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02793908


Contacts
Layout table for location contacts
Contact: Fulvio Zullo, MD, PhD 337947003 zullo@unicz.it

Locations
Layout table for location information
Italy
Magna Graecia University - Azienda Ospedaliera Pugliese Ciaccio Recruiting
Catanzaro, CZ, Italy, 88100
Contact: Fulvio Zullo, MD, PhD    39337947003    zullo@unicz.it   
Principal Investigator: Roberta Venturella, MD         
Sponsors and Collaborators
University Magna Graecia
Investigators
Layout table for investigator information
Study Director: Fulvio Zullo Magna Graecia University of Catanzaro
Principal Investigator: Roberta Venturella Magna Graecia University of Catanzaro

Layout table for additonal information
Responsible Party: Fulvio Zullo, Full Professor, University Magna Graecia
ClinicalTrials.gov Identifier: NCT02793908     History of Changes
Other Study ID Numbers: UMagnaGraecia
First Posted: June 8, 2016    Key Record Dates
Last Update Posted: November 21, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be published at the end of the study.

Keywords provided by Fulvio Zullo, University Magna Graecia:
Endometriosis
Subcutaneous progesterone
luteal phase

Additional relevant MeSH terms:
Layout table for MeSH terms
Endometriosis
Genital Diseases, Female
Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs