Subcutaneous Progesterone Supplementation in Patients With Endometriosis

NCT02793908 | Unknown Phase 3

• 1 other identifier: UMagnaGraecia
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis

Keywords

Endometriosis; Subcutaneous progesterone; luteal phase

Outcome Measures

Primary Outcomes (1)

• Delta VAS pain

  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 Outcomes (2)

• Analgesic use

  7 days after the end of the menstrual period subsequent to the luteal supplementation

• Pregnancy rate

  30 days after the end of the menstrual period subsequent to the luteal supplementation

Study Arms (2)

Pleyris

EXPERIMENTAL

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

Drug: Pleyris

Crinone8

ACTIVE COMPARATOR

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

Drug: Crinone8

Interventions

Pleyris DRUG

Luteal phase will be supplemented starting by the ovulation day for 14 days

Also known as: Subcutaneous progesterone

Pleyris

Crinone8 DRUG

Luteal phase will be supplemented starting by the ovulation day for 14 days

Also known as: vaginal progesterone

Crinone8

Eligibility Criteria

• Age: 18 Years - 38 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Magna Graecia: lead

Study Sites (1)

Magna Graecia University - Azienda Ospedaliera Pugliese Ciaccio

Catanzaro, CZ, 88100, Italy

RECRUITING

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Fulvio Zullo

  Magna Graecia University of Catanzaro

  STUDY DIRECTOR

• Roberta Venturella

  Magna Graecia University of Catanzaro

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fulvio Zullo, MD, PhD

CONTACT

337947003; zullo@unicz.it

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: June 2, 2016
• First Posted: June 8, 2016
• Study Start: June 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: August 1, 2017
• Last Updated: November 21, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will share

Locations

IT (1)