Are the Combined Oral Contraceptive Pills Needed for Management of the Simple Ovarian Cysts in Reproductive Women?

B

Benha University

Status and phase

Unknown
Phase 3
Phase 2

Conditions

Ovary Cyst

Treatments

Drug: combined oral contraceptive pills

Study type

Interventional

Funder types

Other

Identifiers

NCT03357640
khalid4

Details and patient eligibility

About

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.

Full 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.

Enrollment

118 patients

Sex

Female

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

-

Exclusion Criteria:

Exclusion criteria include premenarche, post menopause and neoplastic ovarian swelling (any swelling more than 6cm or multilocular).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

118 participants in 2 patient groups, including a placebo group

no intervention
Placebo Comparator group
Description:
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.
Treatment:
Drug: combined oral contraceptive pills
combined oral contraception pills
Active Comparator group
Description:
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.
Treatment:
Drug: combined oral contraceptive pills

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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