A Phase 2/3 interventional study of combined oral contraceptive pills in Ovary Cyst, sponsored by Benha University. Status unknown at 1 site in Egypt. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-11-30.
Sponsored by Benha University · Phase 2/3, Interventional, and Treatment
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Among 10 studies in Ovarian Cysts with a site in Egypt — 2 open to participants now, 2 under way, none of them phase 3. Ovarian Cysts · Egypt.
Among the 10 studies in Ovarian Cysts with a site in Egypt, this one is one of 2 that started in 2017, is the only one in phase 2/3, and was the 1st registered.
80 studies on the registry are indexed under Ovarian Cysts; 16 are open to participants now.
Browse Ovarian Cysts studies →2 of the 10 studies in Ovarian Cysts with a site in Egypt are open now. Recruiting first, the newest first:
Benha University · Sites in Egypt
Ages 18–45 · Women only
Kafrelsheikh University · Sites in Egypt
Ages 18–50 · Women only
A study can be open while its sites in Egypt have not opened yet or have stopped. Only those recruiting at a site in Egypt →
Of the 12 Ovarian Cysts studies recruiting now, 4 (33%) set no upper age limit and 7 (58%) stop at 75 or younger; 3 take children under 18; 3 take healthy volunteers.
This study: female · healthy volunteers too.
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10 studies; the count open now beside each. This study's row is marked.
First in 2017; this study’s year is marked. 2 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 118 is above the median of 74 across 51 interventional studies indexed under Ovarian Cysts.
Median enrollment 79 across the 9 interventional studies, 1,000 across the 1 observational. Of the 4 that completed or were terminated, 0 (0%) have results posted.
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None of the 10 has an industry lead sponsor. The 8 most frequent:
Benha University is the lead sponsor of 362 studies on the registry; 66 are open to participants now.
Benha University has 2 studies filed under Ovarian Cysts — fewer than ten, so there is no comparison to draw.
1 of the studies in Ovarian Cysts with a site in Egypt that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07686783Benha UniversityOvarian Reserve After Laparoscopic Cystectomy for Endometriotic and Non-Endometriotic Cysts | 2027-06 |
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Among the 10 studies in Ovarian Cysts with a site in Egypt, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Inclusion Criteria:include women in reproductive age ovarian cysts unilateral, 2.5-6 centimeters in diameter, thin wall, unilocular without internal echoes and no solid parts.
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Exclusion Criteria:
Exclusion criteria include premenarche, post menopause and neoplastic ovarian swelling (any swelling more than 6cm or multilocular).
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.
Drug: combined oral contraceptive pills
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.
Drug: combined oral contraceptive pills
one package of oral contraception (Cilest containing norgestimate 250 microgram + ethinyl estradiol 35 microgram)
Also known as: placebo
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.
Time frame: 3 months
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.
Time frame: 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.
Time frame: 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
Time frame: 3 months
Plan to share: Undecided
No publications or documents are linked to this record.
Started May 2017 (actual). Primary completion is estimated for May 2018, 12 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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