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

NCT ID: NCT05293574

Last Updated: 2022-03-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2023-12-01

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 .

Conditions

Ovarian Cyst Simple

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

norethisterone acetate group

. 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 .

Group Type: EXPERIMENTAL

norethisterone acetate

Intervention Type: DRUG

Norethindrone, a progesterone agonist

expectant managment group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

norethisterone acetate

Norethindrone, a progesterone agonist

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 24 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Mostafa Mohamed Swafi

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

abobakr alsokary abbas, prof.dr

Role: PRINCIPAL_INVESTIGATOR

assiut

Central Contacts

mohamed mostafa swafi, dr

Role: CONTACT

swafi1994@gmail.com

01069231210

alaa eldin abdelhamid, prof.dr

Role: CONTACT

alaaeldinabdelhamid60@gmail.com

01222442140

Other Identifiers

simple ovarian cyst

Identifier Type: -

Identifier Source: org_study_id