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

NCT05293574 | Unknown Phase 4

• 1 other identifier: simple ovarian cyst
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ovarian Cyst Simple

Outcome Measures

Primary Outcomes (1)

• randomized control trial between (norethisterone acetate)and expectant management in Treatment of simple Ovarian Cysts

  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 .

  baseline

Study Arms (2)

norethisterone acetate group

EXPERIMENTAL

. 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

expectant managment group

NO INTERVENTION

Interventions

norethisterone acetate DRUG

Norethindrone, a progesterone agonist

norethisterone acetate group

Eligibility Criteria

• Age: 24 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• premenarche
• postmenopause
• current user of Norethisterone acetate.
• those having contraindication from Norethisterone use.
• gynecologic malignancy

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Interventions

Norethindrone Acetate

Intervention Hierarchy (Ancestors)

Norethindrone; Norpregnenes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• abobakr alsokary abbas, prof.dr

  assiut

  PRINCIPAL INVESTIGATOR

Central Study Contacts

mohamed mostafa swafi, dr

CONTACT

01069231210; swafi1994@gmail.com

alaa eldin abdelhamid, prof.dr

CONTACT

01222442140; alaaeldinabdelhamid60@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 1, 2022
• First Posted: March 24, 2022
• Study Start: October 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: December 1, 2023
• Last Updated: March 24, 2022

Record last verified: 2022-03