Ovarian NeoplasmsPhase 3NCT05244811
Treat of Functional Ovarian Cysts by Compare Between Cocs and Progesterone Only Pills
A Phase 3 study testing Combined Oral Contraceptive and Progestin in people with Ovarian Neoplasms, run by Sohag University.
Trial summary
comparison between cocs and progesterone only containing pills in treatment of fuctional ovarian cyst Read more about this study
- Who is it for?
- Ages 18 to 48 years, women only
- Conditions the study is for
- Ovarian Neoplasms
- What is being tested?
- Combined Oral Contraceptive and Progestin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 20 Feb 2022to Jan 2023
- Phase
- Phase 3
- 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 18 to 48 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- The current randomized, clinical trial was performed on females with:-
- functional ovarian cysts (4 to 8 cm in diameter)
- in reproductive age, within the age range of 18 to 48 years, referred to the Clinic of Gynecological Diseases in a private hospital as outpatient The cysts were identified by transvaginal ultrasonography
Who cannot join
- were history of:-
- endometrioma.
- Other non-functional .ovarian neoplasm
- OCPs consumption during the last three months The patients were randomly divided into three equals
Trial locations and contacts
No sites are listed yet.
mamdouh elsemary aaied, dr contact
About this study
Official title: Treatment of Functional Ovarian Cyst Randomised Clinical Trial
comparison between cocs and progesterone only containing pills in treatment of fuctional ovarian cyst
Read the detailed description
Ovarian cyst is a blister-like sac, which is formed on the surface of ovary during or after ovulation . Most of them are made in reproductive age and are harmless ; these cysts do not cause any symptom and are resolved without treatment , but sometimes they cause health problems that require special attention, and even may lead to infertility. Normal function of ovary is the periodic release of ovums and the production of the steroid hormones of estradiol and progesterone . Both activities are integrated in the continuous repetitive process of follicle maturation, ovulation, and corpus luteum formation and regression. Mature follicle is ruptured and releases ovum during ovulation and corpus luteum is produced from empty follicle if pregnancy does not occur corpus luteum is regressed, due to the absence of hCG (human chorionic gonadotropin). Sometimes this procedure does not happen normally, which results in the formation of ovarian cysts Therefore, functional ovarian cysts are different from ovarian growths induced by other pathological problems most of them regress spontaneously in two or three cycles , but if a cyst gets large, it can twist, be ruptured, or bleed and become very painful .
A functional type of ovarian cyst forms because of slight changes in the way of making or releasing an ovum by the ovary . There are two types of such cysts:
- The follicular cyst, which occurs when the sac on ovary does not release an egg and the sac swells up with fluid
- The luteal cyst, which is formed when the sac releases an egg and then reseals and fills with fluid
Most functional ovarian cysts are asymptomatic , the larger the cyst, the more likely the symptom. The symptoms are pain or aching in lower abdomen, menstrual irregularity, vaginal bleeding, dyspareunia, etc.; sometimes the cyst is ruptured and causes peritoneal irritation with presentations such as nausea and vomiting or sudden onset of pain, hemorrhagic cyst, intra-abdominal bleeding, and emergency conditions . Some other manifestations such as nausea and vomiting may be felt before the occurrence of such events . Regular pelvic examination is recommended for some patients with the history of such cysts; they also may need regular sonography . Oral contraceptive pills (OCPs) are prescribed by some physician to shrink the cyst, if it is persistent and makes discomfort . Although it seems that they are not effective enough compared with close observation, and even some researchers reported no benefits for OCPs, some others prescribed them before any surgical practices ; therefore, the current study aimed at evaluating this issue. For this purpose, some patients who referred to a private clinic were selected in order to compare the effect of OCPs with close observation in the clinical management of functional ovarian cysts. dyspareunia, or the cysts may be found accidentally on voluntary sonography without any symptoms.
- Conditions
- Ovarian Neoplasms
- Being tested
- Combined Oral Contraceptive, Progestin
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined Oral ContraceptiveDrug
Also called cyclo progynova
effect of cocs in treatment of ovarian cysts
ProgestinDrug
Also called primalot-nor
effect of progestin in treatment of ovarian cystn
| Study group | Role | What they receive |
|---|---|---|
| use of placebo in treatment of functional ovarian cyst | Placebo comparator | trial the effect of placebo in treatment of functional ovarian cyst Receives: Drug: Combined Oral Contraceptive; Drug: Progestin |
| use of cocs in treatment of functional ovarian cyst | Active comparator | trial of the effectiveness of cocs in the treatment of functional ovarian cyst Receives: Drug: Combined Oral Contraceptive; Drug: Progestin |
| use of progesterone in treatment of functional ovarian cyst | Active comparator | comparison between the effect of progesterone in the treatment of functional ovarian cyst with the effect of cocs Receives: Drug: Combined Oral Contraceptive; Drug: Progestin |
What is being measured
The primary outcome is the main question the study is designed to answer.
treatment of functional ovarian cysts
rate of treatment of combined oral contraceptive pills in functional ovarian cyst compared with cases who will receive progesterone only pills
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start20 Feb 2022 (estimated)
- Primary completionJan 2023 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ovarian NeoplasmsStudies of the same condition, open and under way.
- More trials run by Sohag 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelhamed Khaled Abdelhameed Farghal, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05244811
- Sponsor's protocol ID
- ovarian cysts
- Status last verified
- Feb 2022
- First submitted
- 9 Jan 2022
- Last updated
- 17 Feb 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Formuso C, Stracquadanio M, Ciotta L. Myo-inositol vs. D-chiro inositol in PCOS treatment. Minerva Ginecol. 2015 Aug;67(4):321-5. Epub 2015 Feb 11.
PubMed 25670222Wu XK, Stener-Victorin E, Kuang HY, Ma HL, Gao JS, Xie LZ, Hou LH, Hu ZX, Shao XG, Ge J, Zhang JF, Xue HY, Xu XF, Liang RN, Ma HX, Yang HW, Li WL, Huang DM, Sun Y, Hao CF, Du SM, Yang ZW, Wang X, Yan Y, Chen XH, Fu P, Ding CF, Gao YQ, Zhou ZM, Wang CC, Wu TX, Liu JP, Ng EHY, Legro RS, Zhang H; PCOSAct Study Group. Effect of Acupuncture and Clomiphene in Chinese Women With Polycystic Ovary Syndrome: A Randomized Clinical Trial. JAMA. 2017 Jun 27;317(24):2502-2514. doi: 10.1001/jama.2017.7217.
PubMed 28655015
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Functional Ovarian Cyst Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT05244811
- Acronym / sponsor ID
- ovarian cysts
- Conditions
- Ovarian Neoplasms
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 20 Feb 2022 (estimated)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 17 Feb 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.
comparison between cocs and progesterone only containing pills in treatment of fuctional ovarian cyst
Detailed description
Ovarian cyst is a blister-like sac, which is formed on the surface of ovary during or after ovulation . Most of them are made in reproductive age and are harmless ; these cysts do not cause any symptom and are resolved without treatment , but sometimes they cause health problems that require special attention, and even may lead to infertility. Normal function of ovary is the periodic release of ovums and the production of the steroid hormones of estradiol and progesterone . Both activities are integrated in the continuous repetitive process of follicle maturation, ovulation, and corpus luteum formation and regression. Mature follicle is ruptured and releases ovum during ovulation and corpus luteum is produced from empty follicle if pregnancy does not occur corpus luteum is regressed, due to the absence of hCG (human chorionic gonadotropin). Sometimes this procedure does not happen normally, which results in the formation of ovarian cysts Therefore, functional ovarian cysts are different from ovarian growths induced by other pathological problems most of them regress spontaneously in two or three cycles , but if a cyst gets large, it can twist, be ruptured, or bleed and become very painful .
A functional type of ovarian cyst forms because of slight changes in the way of making or releasing an ovum by the ovary . There are two types of such cysts:
- The follicular cyst, which occurs when the sac on ovary does not release an egg and the sac swells up with fluid
- The luteal cyst, which is formed when the sac releases an egg and then reseals and fills with fluid
Most functional ovarian cysts are asymptomatic , the larger the cyst, the more likely the symptom. The symptoms are pain or aching in lower abdomen, menstrual irregularity, vaginal bleeding, dyspareunia, etc.; sometimes the cyst is ruptured and causes peritoneal irritation with presentations such as nausea and vomiting or sudden onset of pain, hemorrhagic cyst, intra-abdominal bleeding, and emergency conditions . Some other manifestations such as nausea and vomiting may be felt before the occurrence of such events . Regular pelvic examination is recommended for some patients with the history of such cysts; they also may need regular sonography . Oral contraceptive pills (OCPs) are prescribed by some physician to shrink the cyst, if it is persistent and makes discomfort . Although it seems that they are not effective enough compared with close observation, and even some researchers reported no benefits for OCPs, some others prescribed them before any surgical practices ; therefore, the current study aimed at evaluating this issue. For this purpose, some patients who referred to a private clinic were selected in order to compare the effect of OCPs with close observation in the clinical management of functional ovarian cysts. dyspareunia, or the cysts may be found accidentally on voluntary sonography without any symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| use of placebo in treatment of functional ovarian cyst | Placebo comparator | Drug: Combined Oral Contraceptive, Drug: Progestintrial the effect of placebo in treatment of functional ovarian cyst |
| use of cocs in treatment of functional ovarian cyst | Active comparator | Drug: Combined Oral Contraceptive, Drug: Progestintrial of the effectiveness of cocs in the treatment of functional ovarian cyst |
| use of progesterone in treatment of functional ovarian cyst | Active comparator | Drug: Combined Oral Contraceptive, Drug: Progestincomparison between the effect of progesterone in the treatment of functional ovarian cyst with the effect of cocs |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- The current randomized, clinical trial was performed on females with:-
Key exclusion criteria (4 listed)
- were history of:-
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 |
|---|---|---|
| Combined Oral ContraceptiveAlso: cyclo progynovaeffect of cocs in treatment of ovarian cysts | Drug | use of cocs in treatment of functional ovarian cyst, use of placebo in treatment of functional ovarian cyst, use of progesterone in treatment of functional ovarian cyst |
| ProgestinAlso: primalot-noreffect of progestin in treatment of ovarian cystn | Drug | use of cocs in treatment of functional ovarian cyst, use of placebo in treatment of functional ovarian cyst, use of progesterone in treatment of functional ovarian cyst |
Primary outcome
treatment of functional ovarian cysts
Time frame: one year
rate of treatment of combined oral contraceptive pills in functional ovarian cyst compared with cases who will receive progesterone only pills
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2022.
- Background: PubMed 25670222Formuso C, Stracquadanio M, Ciotta L. Myo-inositol vs. D-chiro inositol in PCOS treatment. Minerva Ginecol. 2015 Aug;67(4):321-5. Epub 2015 Feb 11.
- Background: PubMed 28655015Wu XK, Stener-Victorin E, Kuang HY, Ma HL, Gao JS, Xie LZ, Hou LH, Hu ZX, Shao XG, Ge J, Zhang JF, Xue HY, Xu XF, Liang RN, Ma HX, Yang HW, Li WL, Huang DM, Sun Y, Hao CF, Du SM, Yang ZW, Wang X, Yan Y, Chen XH, Fu P, Ding CF, Gao YQ, Zhou ZM, Wang CC, Wu TX, Liu JP, Ng EHY, Legro RS, Zhang H; PCOSAct Study Group. Effect of Acupuncture and Clomiphene in Chinese Women With Polycystic Ovary Syndrome: A Randomized Clinical Trial. JAMA. 2017 Jun 27;317(24):2502-2514. doi: 10.1001/jama.2017.7217.
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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.
mamdouh elsemary aaied, dr contact
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Combined Oral Contraceptive and Progestin in people with Ovarian Neoplasms, run by Sohag 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 3 inclusion and 4 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 17 Feb 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 salah mohamed rasheed, professor (01224653702, salahrasheed67@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
treatment of functional ovarian cysts (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05244811, which also lists 2 linked publications.
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 17 Feb 2022.