Ovarian Cyst SimplePhase 4NCT05293574
A Trial of Norethisterone Acetate and Expectant Management in Treatment of Simple Ovarian Cysts
A Phase 4 study testing norethisterone acetate in people with Ovarian Cyst Simple, run by Assiut University.
Trial summary
To compare the effectiveness of (norethisterone acetate) in the treatment of spontaneously occurring simple ovarian cyst detected by ultrasonography compared with expectant management. Read more about this study
- Who is it for?
- Ages 24 to 49 years, women only
- Conditions the study is for
- Ovarian Cyst Simple
- What is being tested?
- norethisterone acetate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2022to 1 Dec 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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 )
Who cannot join
- premenarche
- postmenopause
- current user of Norethisterone acetate.
- those having contraindication from Norethisterone use.
- gynecologic malignancy
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Randomized Control Trial Between Norethisterone Acetate and Expectant Management in Treatment of Simple Ovarian Cysts
To compare the effectiveness of (norethisterone acetate) in the treatment of spontaneously occurring simple ovarian cyst detected by ultrasonography compared with expectant management.
Read the 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
- Being tested
- norethisterone acetate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
norethisterone acetateDrug
Norethindrone, a progesterone agonist
| Study group | Role | What they receive |
|---|---|---|
| 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 . Receives: Drug: norethisterone acetate |
| expectant managment group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start1 Oct 2022 (estimated)
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian Cyst SimpleStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Mostafa Mohamed Swafi, Assiut University
- Investigators
- abobakr alsokary abbas, prof.dr, Principal investigator, assiut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05293574
- Sponsor's protocol ID
- simple ovarian cyst
- Status last verified
- Mar 2022
- First submitted
- 1 Mar 2022
- Last updated
- 24 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial Between Norethisterone Acetate and Expectant Management in Treatment of Simple Ovarian Cysts
- ClinicalTrials.gov ID
- NCT05293574
- Acronym / sponsor ID
- simple ovarian cyst
- Conditions
- Ovarian Cyst Simple
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 24 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| norethisterone acetate group | Experimental | Drug: 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 . |
| expectant managment group | No intervention | – |
Who may qualify
- Ages
- 24 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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 )
Key exclusion criteria (5 listed)
- premenarche
- postmenopause
- current user of Norethisterone acetate.
- those having contraindication from Norethisterone use.
- gynecologic malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| norethisterone acetateNorethindrone, a progesterone agonist | Drug | norethisterone acetate group |
Primary outcome
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 .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Ovarian Cyst Simple
Recruiting
Save the Ovaries - Surgical Management of Simple Ovarian Cysts in Children and Adolescents
Ovarian Cyst Benign
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
abobakr alsokary abbas, prof.dr principal investigator
assiut
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing norethisterone acetate in people with Ovarian Cyst Simple, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mohamed mostafa swafi, dr (01069231210, swafi1994@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
randomized control trial between (norethisterone acetate)and expectant management in Treatment of simple Ovarian Cysts (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2022.