An Early Phase 1 interventional study of Dydrogesterone 10 mg and Placebo Oral Tablet in Functional Ovarian Cyst and Progesterone, sponsored by Assiut University. Status unknown. Open to female participants aged 18 Years to 44 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-07.
Sponsored by Assiut University · Early Phase 1, Interventional, and Treatment
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
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
80 studies on the registry are indexed under Ovarian Cysts; 16 are open to participants now.
This study's planned enrollment of 90 is above the median of 74 across 51 interventional studies indexed under Ovarian Cysts.
Browse Ovarian Cysts studies →Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Dydrogesterone 10 mg twice daily
Also known as: duphaston 10 mg
oral tablets twice daily
disappearance of cyst
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
Time frame: 2 months
No study locations are listed for this record.
Start is estimated for May 2018; primary completion for May 2020, 24 months later.
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This study is status unknown, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dydrogesterone