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The Efficacy of Progestins in Treatment of Functional Ovarian Cyst

The Efficacy of Progestins in Treatment of Functional Ovarian Cyst

Status
UNKNOWN
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03456570
Enrollment
90
Registered
2018-03-07
Start date
2018-05-01
Completion date
2020-09-01
Last updated
2018-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Functional Ovarian Cyst, Progesterone

Brief summary

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

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

Interventions

Dydrogesterone 10 mg twice daily

DRUGPlacebo Oral Tablet

oral tablets twice daily

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 44 Years
Healthy volunteers
Yes

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

*

Design outcomes

Primary

MeasureTime frameDescription
disappearance of cyst2 monthsultrasound 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

Contacts

Primary Contactamgad saber, bachelor
amgadmagdy59@yahoo.com002 01226082579

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026