Subcutaneous Progesterone Supplementation in Patients With Endometriosis

Endometriosis Clinical Trial

— PleyrisEndom  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02793908
• Other study ID #: UMagnaGraecia
• Status: Recruiting
• Phase: Phase 3
• First received: June 2, 2016
• Last updated: November 17, 2016
• Start date: June 2016
• Est. completion date: August 2017

Study information

• Verified date: November 2016
• Source: University Magna Graecia
• Contact: Fulvio Zullo, MD, PhD
• Phone: 337947003
• Email: zullo[@]unicz.it
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: August 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 38 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endometriosis

Intervention

Drug:
• Pleyris
Luteal phase will be supplemented starting by the ovulation day for 14 days
• Crinone8
Luteal phase will be supplemented starting by the ovulation day for 14 days

Locations

Country	Name	City	State
Italy	Magna Graecia University - Azienda Ospedaliera Pugliese Ciaccio	Catanzaro	CZ

Sponsors (1)

Lead Sponsor	Collaborator
University Magna Graecia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Analgesic use	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	No
Secondary	Pregnancy rate	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	No