The Efficacy of Progestins in Treatment of Functional Ovarian Cyst

Progesterone Clinical Trial

Official title:

The Efficacy of Progestins in Treatment of Functional Ovarian Cyst

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03456570
• Other study ID #: Progestins and ovarian cyst
• Status: Not yet recruiting
• Phase: Early Phase 1
• First received: February 16, 2018
• Last updated: March 6, 2018
• Start date: May 1, 2018
• Est. completion date: September 1, 2020

Study information

• Verified date: March 2018
• Source: Assiut University
• Contact: amgad saber, bachelor
• Phone: 002 01226082579
• Email: amgadmagdy59[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: September 1, 2020
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

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

Related Conditions & MeSH terms

• Cysts
• Functional Ovarian Cyst
• Ovarian Cysts
• Progesterone

Intervention

Drug:
• Dydrogesterone 10 mg
Dydrogesterone 10 mg twice daily
• Placebo Oral Tablet
oral tablets twice daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (2)

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. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	2 months