A Trial of Norethisterone Acetate and Expectant Management in Treatment of Simple Ovarian Cysts

Phase 4

• Conditions: Ovarian Cyst Simple
• Interventions: Drug: norethisterone acetate

• Registration Number: NCT05293574
• Lead Sponsor: Assiut University

Brief Summary

To compare the effectiveness of (norethisterone acetate) in the treatment of spontaneously occurring simple ovarian cyst detected by ultrasonography compared with expectant management.

Detailed Description

An ovarian cyst is a sac filled with liquid or semiliquid material that arises in an ovary. The number of diagnoses of ovarian cysts has increased with the widespread implementation of regular physical examinations and ultrasonographic technology.

The discovery of an ovarian cyst causes considerable anxiety in women who fears of malignancy, but the majority of ovarian cysts are benign.

These cysts can develop in females at any stage of life, from the neonatal period to postmenopause. Most ovarian cysts, occur during adolescence, which are hormonally active periods of development.

Most are functional in nature and some times resolve without treatment. However, ovarian cysts can herald an underlying malignant process or, possibly, distract the clinician from a more dangerous condition, such as ectopic pregnancy, ovarian torsion, or appendicitis.

When ovarian cysts are large, persistent, painful, or have concerning radiographic or exam findings, surgery may be required, sometimes resulting in removal of the ovary. If a cyst does not resolve after several menstrual cycles, it is unlikely to be a functional cyst, and further workup is indicated.

Early epidemiological studies reported an inverse relationship between use of oral contraceptives (OCs) and surgically confirmed functional cysts . Many previous studies have indicated that the use of Oral Contraceptive pills (OC) is associated with a lower risk of occurrence of functional ovarian cysts. few studies have considered the treatment effect of OC on functional ovarian cysts. In current clinical practice, gynecologists treat functional ovarian cysts with either OC or expectant management alone. Several randomized controlled trials have shown no significant difference in the resolution of functional ovarian cysts treated with OC over expectant management alone Functional ovarian cyst can occur due to estrogen hyperstimulaton and some theories conceoted that progesterone treatment can suppress this cyst .

Study Timeline

• Status Verified: 2022-03
• Study First Submitted: 2022-03-01
• Study First Submitted QC: 2022-03-19
• Last Update Submitted: 2022-03-19
• Study First Posted: 2022-03-24
• Last Update Posted: 2022-03-24
• Study Start: 2022-10-01
• Primary Completion: 2023-10-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 66

Inclusion Criteria

1. women at age 24-49 years old
2. women with simple cyst.( with none of the following: solid parts, papillary formations, peritoneal masses, intraabdominal lymph node enlargement or ascites ) .(13)
3. from 5 to10cm in diameter.
4. functioning cyst.( defined as largest dimension between 2-8 cm in diameter, unilateral, uniloculated, thin-walled, anechogenic and has distal acoustic enhancement )

Exclusion Criteria

1. premenarche
2. postmenopause
3. current user of Norethisterone acetate.
4. those having contraindication from Norethisterone use.
5. gynecologic malignancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
norethisterone acetate group	norethisterone acetate	. In the norethisterone acetate group, the women will receive of norethisterone acetate 5 mg twice daily and are counseled about how to take norethisterone acetate and informed of possible side effects. They also receive a diary card for recording norethisterone acetate intake to be returned to the physician on the day of the next visit. An appointment for the women in both groups was scheduled at one month of treatment for the second ultrasonography. If there is no remission occurred another month of Norethisterone acetate will be given .

Primary Outcome Measures

Name	Time	Method
randomized control trial between (norethisterone acetate)and expectant management in Treatment of simple Ovarian Cysts	baseline	Women who had a functional ovarian cyst will be informed about the study.They are then allocated to one or other of the treatment groups (norethisterone acetate or expectant management). the women will be returned to the physician on the day of the next visit. An appointment for the women in both groups was scheduled at one month of treatment for the second ultrasonography. cysts are measured on the day that the participants visited gynecologic clinic by transvaginal or transabdominal US who serviced gynecological patients on a regular basis The following definitions of outcomes were used: Remission, the was defined as ultrasonographic examination being unable to detect the ovarian cyst; Persistence as ultrasonographic examination being able to detect the same ovarian cyst with the same size If there is no remission occurred another month of Norethisterone acetate will be given .