The Efficacy of Progestins in Treatment of Functional Ovarian Cyst

Early Phase 1

• Conditions: Progesterone; Functional Ovarian Cyst
• Interventions: Drug: Placebo Oral Tablet; Drug: Dydrogesterone 10 mg

• Registration Number: NCT03456570
• Lead Sponsor: Assiut University

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

Study Timeline

• Study First Submitted: 2018-02-16
• Status Verified: 2018-03
• Study First Submitted QC: 2018-03-06
• Last Update Submitted: 2018-03-06
• Study First Posted: 2018-03-07
• Last Update Posted: 2018-03-07
• Study Start: 2018-05-01
• Primary Completion: 2020-05-01
• Study Completion: 2020-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 90

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Placebo Oral Tablet	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
progesterone	Dydrogesterone 10 mg	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

Primary Outcome Measures

Name	Time	Method
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; 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