NCT02793908

Subcutaneous Progesterone Supplementation in Patients With Endometriosis

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: University Magna Graecia · Academic / Other
• Sex: Female
• Age: 18 Years – 38 Years
• Healthy volunteers: Not accepted

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

Conditions

• Endometriosis

Interventions

Type	Name	Description
DRUG	Pleyris	Luteal phase will be supplemented starting by the ovulation day for 14 days
DRUG	Crinone8	Luteal phase will be supplemented starting by the ovulation day for 14 days

Timeline

• Start date: 2016-06-01
• Primary completion: 2017-06-01
• Completion: 2017-08-01
• First posted: 2016-06-08
• Last updated: 2016-11-21

Locations

1 site across 1 country: Italy