NCT07876037

Brief Summary

To evaluate the therapeutic effect of combined oral contraceptive pills in women with benign post-hysterectomy ovarian cysts.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 30, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2025

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 3, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 15, 2026

Completed
Last Updated

October 15, 2026

Status Verified

August 1, 2024

Enrollment Period

1 year

First QC Date

October 3, 2026

Last Update Submit

October 11, 2026

Conditions

HysterectomyOvarian CystContraceptive

Keywords

Oral Contraceptive PillsWomanOvarian CystHysterectomy

Outcome Measures

Primary Outcomes (1)

  • Incidence of cyst regression

    at 3 months or 6 months

Secondary Outcomes (1)

  • occurrence of complications

    at 3 months or 6 months

Study Arms (2)

Group 1 (Control group)

PLACEBO COMPARATOR

Women received folic acid treatment (placebo effect).

Drug: Group 1 (Control group)

Group 2 (Study group)

EXPERIMENTAL

Women received combined oral contraceptive pills for 3 months (continuous daily) and then follow up after 6 months.

Drug: Group 2 (Study group)

Interventions

Group 1 (Control group)DRUG

Women received folic acid treatment (placebo effect).

Group 1 (Control group)
Group 2 (Study group)DRUG

Women received combined oral contraceptive pills (COCP) for 3 months (continuous daily) and then follow up after 6 months.

Group 2 (Study group)

Eligibility Criteria

Age40 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age ≥ 40 years old,
  • patient with post-hysterectomy ovarian cyst with the simple ovarian cyst with no septation or solid cyst,
  • woman with preoperative normal ovaries.

You may not qualify if:

  • data of previous hysterectomy was deficient,
  • infected cyst,
  • suspicious cyst.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University

Tanta, Egypt

Location

MeSH Terms

Conditions

Ovarian Cysts

Interventions

Control Groups

Condition Hierarchy (Ancestors)

CystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident of Obstetrics and Gynecology Department, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

First Submitted

October 3, 2026

First Posted

October 15, 2026

Study Start

August 30, 2024

Primary Completion

August 30, 2025

Study Completion

August 30, 2025

Last Updated

October 15, 2026

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will share

It will be available if it needed

Shared Documents
STUDY PROTOCOL, ICF

Locations

EG(1)