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

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ClinicalTrials.gov Identifier: NCT05293574
Recruitment Status : Not yet recruiting
First Posted : March 24, 2022
Last Update Posted : March 24, 2022
Sponsor:
Information provided by (Responsible Party):
Mohamed Mostafa Mohamed Swafi, 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.

Condition or disease Intervention/treatment Phase
Ovarian Cyst Simple Drug: norethisterone acetate Phase 4

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 .

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Control Trial Between Norethisterone Acetate and Expectant Management in Treatment of Simple Ovarian Cysts
Estimated Study Start Date : October 1, 2022
Estimated Primary Completion Date : October 1, 2023
Estimated Study Completion Date : December 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cysts

Arm Intervention/treatment
Experimental: 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 .

Drug: norethisterone acetate
Norethindrone, a progesterone agonist

No Intervention: expectant managment group



Primary Outcome Measures :
  1. randomized control trial between (norethisterone acetate)and expectant management in Treatment of simple Ovarian Cysts [ Time Frame: 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 .



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Ages Eligible for Study:   24 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05293574


Contacts
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Contact: mohamed mostafa swafi, dr 01069231210 swafi1994@gmail.com
Contact: alaa eldin abdelhamid, prof.dr 01222442140 alaaeldinabdelhamid60@gmail.com

Sponsors and Collaborators
Assiut University
Investigators
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Principal Investigator: abobakr alsokary abbas, prof.dr assiut
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Responsible Party: Mohamed Mostafa Mohamed Swafi, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier: NCT05293574    
Other Study ID Numbers: simple ovarian cyst
First Posted: March 24, 2022    Key Record Dates
Last Update Posted: March 24, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cysts
Ovarian Cysts
Neoplasms
Pathological Conditions, Anatomical
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Norethindrone
Norethindrone Acetate
Contraceptives, Oral, Hormonal
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Hormonal
Contraceptives, Oral, Synthetic