The Efficacy of Progestins in Treatment of Functional Ovarian Cyst

March 6, 2018 updated by: amgad magdy saber, Assiut University
The aim of this study is to determine whether the use of progesterone only pills has a beneficial effect over the expectant management of functional ovarian cyst or not , through a sample of female patients within the reproductive years

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

An ovarian cyst is a common gynecological problem and is divided into 2 main categories; physiological and pathological In relative frequency, functional cysts account for about 24% of all ovarian cysts, benign cysts 70% and malignant 6% Functional cysts are the most common masses seen in the premenopausal ovary and are estimated to affect 8%-20% of reproductive-aged women

Pain or discomfort in the lower abdomen Severe pain from torsion (twisting) or rupture - Cyst rupture is characterized by sudden, sharp, unilateral pelvic pain; this can be associated with trauma, exercise, or coitus. Cyst rupture can lead to peritoneal signs, abdominal distention, and bleeding (which is usually self-limited) Discomfort with intercourse, particularly deep penetration Changes in bowel movements such as constipation Pelvic pressure causing tenesmus or urinary frequency Menstrual irregularities Precocious puberty and early menarche in young children Abdominal fullness and bloating Indigestion, heartburn, or early satiety Hyperpyrexia - This may result from some complications of ovarian cysts, such as ovarian torsion Adnexal or cervical motion tenderness In current clinical practice , gynecologists treat functional ovarian cysts with either oral Contraceptive pills or expectant management alone. we presume using progesterone only pills for treatment of functional ovarian cyst

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 44 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female patients at reproductive age (18-44) Menstruating ovarian cyst (a cyst 3-10 cm in diameter, unilateral , unilocular ,clear content) BMI : patients with normal BMI (18.5-24.9) and overweight (25-29.9) included

Exclusion Criteria:

  • Exclusion criteria are ovarian payhology (dermoid, endometriosis or malignancies)

Complicated cyst (rupture, torsion) Patients receiving hormonal treatment for the previous 3 cycles History of surgical removal of ovarian cyst Comorbidities like uncontrolled DM ,hypertension and tuberculosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: progesterone
these patients will be offered Dydrogesterone 10 mg twice daily will be offered for 10 days , then they will be seen Post-menstrual or delayed menses for 1 week after treatment
Drug: Dydrogesterone 10 mg
Dydrogesterone 10 mg twice daily
Other Names:
  • duphaston 10 mg
Placebo Comparator: placebo
those patients will be offered placebo tablets twice daily will be offered for 10 days , then they will be seen Post-menstrual or delayed menses for 1 week after treatment
Drug: Placebo Oral Tablet
oral tablets twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
disappearance of cyst
Time Frame: 2 months

ultrasound evaluation

Post-menstrual or delayed menses for 1 week after treatment Patients will be asked about residual symptoms Then TVUS if

  1. resolved , another examination will be scheduled after 1 month post-menstrual
  2. decreasing in size , another course of treatment will be offered
  3. stationary or increasing ,patient will be offered COCs (0.15 mg levonorgestrel and 0.03 mg ethinyl estradiol)
  4. complicated ( torsion or rupture ) , patient will be subjected to surgery
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: amgad saber, bachelor, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2018

Primary Completion (Anticipated)

May 1, 2020

Study Completion (Anticipated)

September 1, 2020

Study Registration Dates

First Submitted

February 16, 2018

First Submitted That Met QC Criteria

March 6, 2018

First Posted (Actual)

March 7, 2018

Study Record Updates

Last Update Posted (Actual)

March 7, 2018

Last Update Submitted That Met QC Criteria

March 6, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Progestins and ovarian cyst

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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