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

NCT03357640 | Unknown Phase 2 DMC

• 1 other identifier: khalid4
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ovary Cyst

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Regression

  3 months

• Progression

  3 months

• Persistence

  3 months

Study Arms (2)

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.

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.

Drug: combined oral contraceptive pills

Interventions

combined oral contraceptive pills DRUG

one package of oral contraception (Cilest containing norgestimate 250 microgram + ethinyl estradiol 35 microgram)

Also known as: placebo

combined oral contraception pills; no intervention

Eligibility Criteria

• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha university

Banhā, Al Qalubia, Egypt

Location

MeSH Terms

Conditions

Ovarian Cysts

Condition Hierarchy (Ancestors)

Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Mohammed K Alloush

  Benha University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Both trial participants and research coordinator will be blinded about the treatment after assignment. Oral contraceptive pills and placebo will be put in 2 packages with different colors and only the main researcher will know the type of treatment used for each group. Unbinding is only permissible, if sever morbidity or even mortality occur to any participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistent professor

Study Record Dates

• First Submitted: November 24, 2017
• First Posted: November 30, 2017
• Study Start: May 1, 2017
• Primary Completion: May 1, 2018
• Study Completion: June 1, 2018
• Last Updated: November 30, 2017

Record last verified: 2017-11

Locations

EG (1)