Subcutaneous Progesterone Supplementation in Patients With Endometriosis
NCT ID: NCT02793908
Last Updated: 2016-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
52 participants
INTERVENTIONAL
2016-06-30
2017-08-31
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Pleyris
Subcutaneous progesterone will be administered 25 mg a day from the day following the ovulation for 14 days
Pleyris
Luteal phase will be supplemented starting by the ovulation day for 14 days
Crinone8
Vaginal progesterone will be administered 90 mg a day from the day following the ovulation for 14 days
Crinone8
Luteal phase will be supplemented starting by the ovulation day for 14 days
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
38 Years
FEMALE
No
Sponsors
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University Magna Graecia
OTHER
Responsible Party
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Fulvio Zullo
Full Professor
Principal Investigators
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Fulvio Zullo
Role: STUDY_DIRECTOR
Magna Graecia University of Catanzaro
Roberta Venturella
Role: PRINCIPAL_INVESTIGATOR
Magna Graecia University of Catanzaro
Locations
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Magna Graecia University - Azienda Ospedaliera Pugliese Ciaccio
Catanzaro, CZ, Italy
Countries
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Central Contacts
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Facility Contacts
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Fulvio Zullo, MD, PhD
Role: primary
Other Identifiers
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UMagnaGraecia
Identifier Type: -
Identifier Source: org_study_id