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

Ovary Cyst Clinical Trial

Official title:

Are the Combined Oral Contraceptive Pills Needed for Management of the Simple Ovarian Cysts in Reproductive Women? (Randomized Controlled Study)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03357640
• Other study ID #: khalid4
• Status: Enrolling by invitation
• Phase: Phase 2/Phase 3
• First received: November 24, 2017
• Last updated: November 24, 2017
• Start date: May 1, 2017
• Est. completion date: June 2018

Study information

• Verified date: November 2017
• Source: Benha University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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, 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 118
• Est. completion date: June 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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).

Related Conditions & MeSH terms

• Cysts
• Ovarian Cysts
• Ovary Cyst

Intervention

Drug:
• combined oral contraceptive pills
one package of oral contraception (Cilest containing norgestimate 250 microgram + ethinyl estradiol 35 microgram)

Locations

Country	Name	City	State
Egypt	Benha university	Banha	Al Qalubia

Sponsors (1)

Lead Sponsor	Collaborator
Benha University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months
Secondary	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.	3 months
Secondary	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.	3 months
Secondary	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	3 months