The Efficacy of Progestins in Treatment of Functional Ovarian Cyst
1 other identifier
interventional
90
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started May 2018
Typical duration for early_phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 16, 2018
CompletedFirst Posted
Study publicly available on registry
March 7, 2018
CompletedStudy Start
First participant enrolled
May 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2020
CompletedMarch 7, 2018
March 1, 2018
2 years
February 16, 2018
March 6, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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 1. resolved , another examination will be scheduled after 1 month post-menstrual 2. decreasing in size , another course of treatment will be offered 3. stationary or increasing ,patient will be offered COCs (0.15 mg levonorgestrel and 0.03 mg ethinyl estradiol) 4. complicated ( torsion or rupture ) , patient will be subjected to surgery
2 months
Study Arms (2)
progesterone
ACTIVE COMPARATORthese 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
placebo
PLACEBO COMPARATORthose 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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
Grimes DA, Jones LB, Lopez LM, Schulz KF. Oral contraceptives for functional ovarian cysts. Cochrane Database Syst Rev. 2014 Apr 29;2014(4):CD006134. doi: 10.1002/14651858.CD006134.pub5.
PMID: 24782304BACKGROUNDGoh 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.
PMID: 24614018BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
amgad saber, bachelor
Assiut University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 16, 2018
First Posted
March 7, 2018
Study Start
May 1, 2018
Primary Completion
May 1, 2020
Study Completion
September 1, 2020
Last Updated
March 7, 2018
Record last verified: 2018-03