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The Efficacy of Progestins in Treatment of Functional Ovarian Cyst

Primary Purpose

Functional Ovarian Cyst, Progesterone

Status
Unknown status
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Dydrogesterone 10 mg
Placebo Oral Tablet
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Functional Ovarian Cyst

Eligibility Criteria

18 Years - 44 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Female patients at reproductive age (18-44) Menstruating ovarian cyst (a cyst 3-10 cm in diameter, unilateral , unilocular ,clear content) BMI : patients with normal BMI (18.5-24.9) and overweight (25-29.9) included

Exclusion Criteria:

  • Exclusion criteria are ovarian payhology (dermoid, endometriosis or malignancies)

Complicated cyst (rupture, torsion) Patients receiving hormonal treatment for the previous 3 cycles History of surgical removal of ovarian cyst Comorbidities like uncontrolled DM ,hypertension and tuberculosis

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    progesterone

    placebo

    Arm Description

    these patients will be offered Dydrogesterone 10 mg twice daily will be offered for 10 days , then they will be seen Post-menstrual or delayed menses for 1 week after treatment

    those patients will be offered placebo tablets twice daily will be offered for 10 days , then they will be seen Post-menstrual or delayed menses for 1 week after treatment

    Outcomes

    Primary Outcome Measures

    disappearance of cyst
    ultrasound evaluation Post-menstrual or delayed menses for 1 week after treatment Patients will be asked about residual symptoms Then TVUS if resolved , another examination will be scheduled after 1 month post-menstrual decreasing in size , another course of treatment will be offered stationary or increasing ,patient will be offered COCs (0.15 mg levonorgestrel and 0.03 mg ethinyl estradiol) complicated ( torsion or rupture ) , patient will be subjected to surgery

    Secondary Outcome Measures

    Full Information

    First Posted
    February 16, 2018
    Last Updated
    March 6, 2018
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03456570
    Brief Title
    The Efficacy of Progestins in Treatment of Functional Ovarian Cyst
    Official Title
    The Efficacy of Progestins in Treatment of Functional Ovarian Cyst
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 1, 2018 (Anticipated)
    Primary Completion Date
    May 1, 2020 (Anticipated)
    Study Completion Date
    September 1, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The aim of this study is to determine whether the use of progesterone only pills has a beneficial effect over the expectant management of functional ovarian cyst or not , through a sample of female patients within the reproductive years
    Detailed Description
    An ovarian cyst is a common gynecological problem and is divided into 2 main categories; physiological and pathological In relative frequency, functional cysts account for about 24% of all ovarian cysts, benign cysts 70% and malignant 6% Functional cysts are the most common masses seen in the premenopausal ovary and are estimated to affect 8%-20% of reproductive-aged women Pain or discomfort in the lower abdomen Severe pain from torsion (twisting) or rupture - Cyst rupture is characterized by sudden, sharp, unilateral pelvic pain; this can be associated with trauma, exercise, or coitus. Cyst rupture can lead to peritoneal signs, abdominal distention, and bleeding (which is usually self-limited) Discomfort with intercourse, particularly deep penetration Changes in bowel movements such as constipation Pelvic pressure causing tenesmus or urinary frequency Menstrual irregularities Precocious puberty and early menarche in young children Abdominal fullness and bloating Indigestion, heartburn, or early satiety Hyperpyrexia - This may result from some complications of ovarian cysts, such as ovarian torsion Adnexal or cervical motion tenderness In current clinical practice , gynecologists treat functional ovarian cysts with either oral Contraceptive pills or expectant management alone. we presume using progesterone only pills for treatment of functional ovarian cyst

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Functional Ovarian Cyst, Progesterone

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    90 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    progesterone
    Arm Type
    Active Comparator
    Arm Description
    these patients will be offered Dydrogesterone 10 mg twice daily will be offered for 10 days , then they will be seen Post-menstrual or delayed menses for 1 week after treatment
    Arm Title
    placebo
    Arm Type
    Placebo Comparator
    Arm Description
    those patients will be offered placebo tablets twice daily will be offered for 10 days , then they will be seen Post-menstrual or delayed menses for 1 week after treatment
    Intervention Type
    Drug
    Intervention Name(s)
    Dydrogesterone 10 mg
    Other Intervention Name(s)
    duphaston 10 mg
    Intervention Description
    Dydrogesterone 10 mg twice daily
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo Oral Tablet
    Intervention Description
    oral tablets twice daily
    Primary Outcome Measure Information:
    Title
    disappearance of cyst
    Description
    ultrasound evaluation Post-menstrual or delayed menses for 1 week after treatment Patients will be asked about residual symptoms Then TVUS if resolved , another examination will be scheduled after 1 month post-menstrual decreasing in size , another course of treatment will be offered stationary or increasing ,patient will be offered COCs (0.15 mg levonorgestrel and 0.03 mg ethinyl estradiol) complicated ( torsion or rupture ) , patient will be subjected to surgery
    Time Frame
    2 months

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    44 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Female patients at reproductive age (18-44) Menstruating ovarian cyst (a cyst 3-10 cm in diameter, unilateral , unilocular ,clear content) BMI : patients with normal BMI (18.5-24.9) and overweight (25-29.9) included Exclusion Criteria: Exclusion criteria are ovarian payhology (dermoid, endometriosis or malignancies) Complicated cyst (rupture, torsion) Patients receiving hormonal treatment for the previous 3 cycles History of surgical removal of ovarian cyst Comorbidities like uncontrolled DM ,hypertension and tuberculosis
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    amgad saber, bachelor
    Phone
    002 01226082579
    Email
    amgadmagdy59@yahoo.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    amgad saber, bachelor
    Organizational Affiliation
    Assiut University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    24782304
    Citation
    Grimes DA, Jones LB, Lopez LM, Schulz KF. Oral contraceptives for functional ovarian cysts. Cochrane Database Syst Rev. 2014 Apr 29;(4):CD006134. doi: 10.1002/14651858.CD006134.pub5.
    Results Reference
    background
    PubMed Identifier
    24614018
    Citation
    Goh W, Bohrer J, Zalud I. Management of the adnexal mass in pregnancy. Curr Opin Obstet Gynecol. 2014 Apr;26(2):49-53. doi: 10.1097/GCO.0000000000000048.
    Results Reference
    background

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    The Efficacy of Progestins in Treatment of Functional Ovarian Cyst

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