Ovary CystPhase 2/3NCT03357640
Are the Combined Oral Contraceptive Pills Needed for Management of the Simple Ovarian Cysts in Reproductive Women?
A Phase 2/3 study testing combined oral contraceptive pills in people with Ovary Cyst, run by Benha University at 1 site in Egypt.
Trial summary
Women will be managed by either of the two modalities and will be followed up by transvaginal ultrasound monthly for three successive months to evaluate the size and location of the functional ovarian cyst (follicular), to compare the effect of different modalities of management whether remission, regression… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ovary Cyst
- What is being tested?
- combined oral contraceptive pills
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 118 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2017to Jun 2018
- Phase
- Phase 2/3
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Exclusion criteria include premenarche, post menopause and neoplastic ovarian swelling (any swelling more than 6cm or multilocular).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Are the Combined Oral Contraceptive Pills Needed for Management of the Simple Ovarian Cysts in Reproductive Women? (Randomized Controlled Study)
Women will be managed by either of the two modalities and will be followed up by transvaginal ultrasound monthly for three successive months to evaluate the size and location of the functional ovarian cyst (follicular), to compare the effect of different modalities of management whether remission, regression, progression or persistence of functional ovarian cyst.
The women will be assigned randomly to either study group to take oral contraceptive pills or to control group to take placebo. The 2 groups will be treated and followed up equally. Oral contraceptive pills will be given to the study group as follow:
The women will receive one package of oral contraception (Cilest containing norgestimate 250 microgram + ethinyl estradiol 35 microgram) and will be counseled about how to take oral contraception and informed of possible side effects. They also will receive a diary card for recording oral contraception intake to be returned to the physician on the next period. An appointment for the women in this group will be scheduled at one month of treatment for the second ultra-sonography. If the ovarian cyst does not show remission, the women will continue the same treatment and will follow up in another month by transvaginal ultra-sound. If the ovarian cyst still persists or progresses at the second month, the women will be followed up for third month. All results of the two groups will be compared. Data will be collected, tabulated according to the standard statistical method.
Read the detailed description
Women will be managed by either of the two modalities and will be followed up by transvaginal ultrasound monthly for three successive months to evaluate the size and location of the functional ovarian cyst (follicular), to compare the effect of different modalities of management whether remission, regression, progression or persistence of functional ovarian cyst.
The women will be assigned randomly to either study group to take oral contraceptive pills or to control group to take placebo. The 2 groups will be treated and followed up equally. Oral contraceptive pills will be given to the study group as follow:
The women will receive one package of oral contraception (Cilest containing norgestimate 250 microgram + ethinyl estradiol 35 microgram) and will be counseled about how to take oral contraception and informed of possible side effects. They also will receive a diary card for recording oral contraception intake to be returned to the physician on the next period. An appointment for the women in this group will be scheduled at one month of treatment for the second ultra-sonography. If the ovarian cyst does not show remission, the women will continue the same treatment and will follow up in another month by transvaginal ultra-sound. If the ovarian cyst still persists or progresses at the second month, the women will be followed up for third month. All results of the two groups will be compared. Data will be collected, tabulated according to the standard statistical method.
- Conditions
- Ovary Cyst
- Being tested
- combined oral contraceptive pills
- Medical subject headings
- Ovarian Cysts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combined oral contraceptive pillsDrug
Also called placebo
one package of oral contraception (Cilest containing norgestimate 250 microgram + ethinyl estradiol 35 microgram)
| Study group | Role | What they receive |
|---|---|---|
| no intervention | Placebo comparator | The women will receive one package of placebo. They also will receive a diary card for recording oral contraception intake to be returned to the physician on the next period. An appointment for the women in this group will be scheduled at one month of treatment for the second ultra-sonography. If the ovarian cyst does not show remission, the women will continue the same treatment and will follow up in another month by transvaginal ultra-sound. If the ovarian cyst still persists or progresses at the second month, the women will be followed up for third month. Receives: Drug: combined oral contraceptive pills |
| combined oral contraception pills | Active comparator | The women will receive intervention of one package of combined oral contraception pills and will be counseled about how to take oral contraception and informed of possible side effects. They also will receive a diary card for recording oral contraception intake to be returned to the physician on the next period. An appointment for the women in this group will be scheduled at one month of treatment for the second ultra-sonography. If the ovarian cyst does not show remission, the women will continue the same treatment and will follow up in another month by transvaginal ultra-sound. If the ovarian cyst still persists or progresses at the second month, the women will be followed up for third month. Receives: Drug: combined oral contraceptive pills |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remission
The main outcome measure and was defined as ultrasonographic examination being unable to detect the ovarian cyst or the cyst being less than 2 centimeters in the largest dimension.
Measured: 3 months
Secondary outcomes (3)
Regression
Was defined as ultrasonographic examination being able to detect the same ovarian cyst at more than 2 centimeters in size, but with the largest dimension having decreased more than 50% of the pre-treatment measurement.
Measured: 3 months
Progression
Was defined as ultrasonographic examination being able to detect the same ovarian cyst with the largest dimension having increased more than 25% of the pre-treatment measurement.
Measured: 3 months
Persistence
Was defined as ultrasonographic examination being able to detect the same ovarian cyst with the same size or with a decrease in the largest dimension of less than 50% or an increase in the largest dimension of less than 25% of the pre-treatment measurement
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2017
- Study start1 May 2017
- Primary completionMay 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovary CystStudies of the same condition, open and under way.
- More trials run by Benha 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, khalid mohammed salama, Benha University
- Investigators
- Mohammed K Alloush, Study director, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03357640
- Sponsor's protocol ID
- khalid4
- Status last verified
- Nov 2017
- First submitted
- 24 Nov 2017
- Last updated
- 30 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- 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 30 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are the Combined Oral Contraceptive Pills Needed for Management of the Simple Ovarian Cysts in Reproductive Women? (Randomized Controlled Study)
- ClinicalTrials.gov ID
- NCT03357640
- Acronym / sponsor ID
- khalid4
- Conditions
- Ovary Cyst
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- May 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 30 Nov 2017 (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.
Women will be managed by either of the two modalities and will be followed up by transvaginal ultrasound monthly for three successive months to evaluate the size and location of the functional ovarian cyst (follicular), to compare the effect of different modalities of management whether remission, regression, progression or persistence of functional ovarian cyst.
The women will be assigned randomly to either study group to take oral contraceptive pills or to control group to take placebo. The 2 groups will be treated and followed up equally. Oral contraceptive pills will be given to the study group as follow:
The women will receive one package of oral contraception (Cilest containing norgestimate 250 microgram + ethinyl estradiol 35 microgram) and will be counseled about how to take oral contraception and informed of possible side effects. They also will receive a diary card for recording oral contraception intake to be returned to the physician on the next period. An appointment for the women in this group will be scheduled at one month of treatment for the second ultra-sonography. If the ovarian cyst does not show remission, the women will continue the same treatment and will follow up in another month by transvaginal ultra-sound. If the ovarian cyst still persists or progresses at the second month, the women will be followed up for third month. All results of the two groups will be compared. Data will be collected, tabulated according to the standard statistical method.
Detailed description
Women will be managed by either of the two modalities and will be followed up by transvaginal ultrasound monthly for three successive months to evaluate the size and location of the functional ovarian cyst (follicular), to compare the effect of different modalities of management whether remission, regression, progression or persistence of functional ovarian cyst.
The women will be assigned randomly to either study group to take oral contraceptive pills or to control group to take placebo. The 2 groups will be treated and followed up equally. Oral contraceptive pills will be given to the study group as follow:
The women will receive one package of oral contraception (Cilest containing norgestimate 250 microgram + ethinyl estradiol 35 microgram) and will be counseled about how to take oral contraception and informed of possible side effects. They also will receive a diary card for recording oral contraception intake to be returned to the physician on the next period. An appointment for the women in this group will be scheduled at one month of treatment for the second ultra-sonography. If the ovarian cyst does not show remission, the women will continue the same treatment and will follow up in another month by transvaginal ultra-sound. If the ovarian cyst still persists or progresses at the second month, the women will be followed up for third month. All results of the two groups will be compared. Data will be collected, tabulated according to the standard statistical method.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| no intervention | Placebo comparator | Drug: combined oral contraceptive pillsThe women will receive one package of placebo. They also will receive a diary card for recording oral contraception intake to be returned to the physician on the next period. An appointment for the women in this group will be scheduled at one month of treatment for the second ultra-sonography. If the ovarian cyst does not show remission, the women will continue the same treatment and will follow up in another month by transvaginal ultra-sound. If the ovarian cyst still persists or progresses at the second month, the women will be followed up for third month. |
| combined oral contraception pills | Active comparator | Drug: combined oral contraceptive pillsThe women will receive intervention of one package of combined oral contraception pills and will be counseled about how to take oral contraception and informed of possible side effects. They also will receive a diary card for recording oral contraception intake to be returned to the physician on the next period. An appointment for the women in this group will be scheduled at one month of treatment for the second ultra-sonography. If the ovarian cyst does not show remission, the women will continue the same treatment and will follow up in another month by transvaginal ultra-sound. If the ovarian cyst still persists or progresses at the second month, the women will be followed up for third month. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Exclusion criteria include premenarche, post menopause and neoplastic ovarian swelling (any swelling more than 6cm or multilocular).
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 contraceptive pillsAlso: placeboone package of oral contraception (Cilest containing norgestimate 250 microgram + ethinyl estradiol 35 microgram) | Drug | combined oral contraception pills, no intervention |
Primary outcome
Remission
Time frame: 3 months
The main outcome measure and was defined as ultrasonographic examination being unable to detect the ovarian cyst or the cyst being less than 2 centimeters in the largest dimension.
3 secondary outcomes
Regression
Time frame: 3 months
Progression
Time frame: 3 months
Persistence
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2017.
- Individual participant dataSharing planned: Undecided
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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.
Mohammed K Alloush study director
Benha University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing combined oral contraceptive pills in people with Ovary Cyst, run by Benha University at 1 site in Egypt.
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 0 inclusion and 1 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 30 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remission (time frame: 3 months). 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 30 Nov 2017.