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The Efficacy of Progestins in Treatment of Functional Ovarian Cyst

Sponsor
Assiut University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03456570
Collaborator
(none)
90
Enrollment
2
Arms
28.1
Anticipated Duration (Months)

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Dydrogesterone 10 mg
  • Drug: Placebo Oral Tablet
 Early Phase 1

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
The Efficacy of Progestins in Treatment of Functional Ovarian Cyst
Anticipated Study Start Date :
May 1, 2018
Anticipated Primary Completion Date :
May 1, 2020
Anticipated Study Completion Date :
Sep 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: progesterone

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

Drug: Dydrogesterone 10 mg
Dydrogesterone 10 mg twice daily
Other Names:
  • duphaston 10 mg

    		•
    Placebo Comparator: placebo

    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

    Drug: Placebo Oral Tablet
    oral tablets twice daily

    Outcome Measures

    Primary Outcome Measures

    1. disappearance of cyst [2 months]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 44 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assiut University

    Investigators

    • Principal Investigator: amgad saber, bachelor, Assiut University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    amgad magdy saber, Principal Investigator, Assiut University
    ClinicalTrials.gov Identifier:
    NCT03456570
    Other Study ID Numbers:
    • Progestins and ovarian cyst
    First Posted:
    Mar 7, 2018
    Last Update Posted:
    Mar 7, 2018
    Last Verified:
    Mar 1, 2018
    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
    Additional relevant MeSH terms:
    Cysts
    Ovarian Cysts
    Dydrogesterone

    Study Results

    No Results Posted as of Mar 7, 2018