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

About this trial
This is an interventional treatment trial for Functional Ovarian Cyst
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
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
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
Learn more about this trial
The Efficacy of Progestins in Treatment of Functional Ovarian Cyst
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