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IRCT20140820018866N10 IRCT 2023-01-05 Tehran University of Medical Sciences Comparison of the effects of vaginal estradiol and evening primrose pills in improving the visualization of the cervix during colposcopy Comparison of Vaginal Estrogen and Evening-primrose Tablets on Transformation Zone Visibility in Unsatisfactory Colposcopy 2023-01-21 anticipated 134 Complete https://irct.ir/trial/63170 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Diagnostic, Randomization description: The randomization process will be done using the website www.sealedenvelope.com and in block form. The number of blocks will be 6, Blinding description: Concealment Type: Sealed Envelope How to conceal: The random allocation list of patients will only be at the disposal of the plan's epidemiologist. In order to hide the random allocation process, a number of 134 sealed envelopes are prepared and a random 10-digit code is written on each envelope, which is the identification number of the relevant intervention, and only the methodologist of the project will be aware of the relevant code. All the envelopes are placed in a box in order based on the random allocation list and given to the person responsible for sampling. When the doctor declares the eligibility of a patient, the sampler will provide the envelope design to the doctor. The desired treatment is selected based on the type of treatment mentioned in the envelope. 3 Cesarean. Intervention 1: Intervention group: Daily conjugated estrogen vaginal cream (one applicator) vaginally for 3 consecutive weeks. Intervention 2: Intervention group: Taking evening primrose tablets (manufactured by Iran's Barij Essential Oil Company) in a dose of 1000 mg vaginally for 3 consecutive weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is It is not yet known if there will be a plan to make this available
public Dr. Afsaneh Tehranian
Arash hospital, Tehranpars, Resalat highway
Tehran Iran (Islamic Republic of) 1653915981 +98 21 7788 3283 afsanehtehranian@yahoo.com Tehran University of Medical Sciences scientific Dr. Afsaneh Tehranian
Arash hospital, Tehranpars, Resalat highway
Tehran Iran (Islamic Republic of) 1653915981 +98 21 7788 3283 afsanehtehranian@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Women who are candidates for colposcopy and have an unsatisfactory colposcopy no limit no limit Female Cervical structural anomalies such as history of cervical insufficiency, Müllerian anomaly and history of conization Having contraindications or sensitivity to evening primrose or estradiol Cancer in the patient or a history of breast or ovarian cancer in the family History of smoking Active vaginal bleeding or pregnancy Post-menopausal women with an inflammatory pap smear or persistent vaginal discharge Taking aspirin or Flavix History of cardiovascular diseases and thromboembolism, sexually transmitted diseases, digestive diseases and neurological diseases, hypertension and coagulopathy, liver disease Thyroid dysfunction and thyroid medication use Blood disorders O82 Encounter for cesarean delivery without indication Treatment - Drugs Treatment - Drugs Intervention group: Daily conjugated estrogen vaginal cream (one applicator) vaginally for 3 consecutive weeks Intervention group: Taking evening primrose tablets (manufactured by Iran's Barij Essential Oil Company) in a dose of 1000 mg vaginally for 3 consecutive weeks. Satisfactoryness of colposcopy. Timepoint: 4 weeks after the start of drug administration. Method of measurement: colposcopy. Side effects such as stomach pain, breast pain, bloating, headache, itching, nausea and vomiting, diarrhea, chest or leg pain, impaired vision or speech, skin sensitivity, abnormal vaginal bleeding, vaginal itching and irritation. Timepoint: 4 weeks after the start of drug administration. Method of measurement: Ask the patient. Tehran University of Medical Sciences Approved 2022-03-16 Ethics committee of Tehran University of Medical Science Tehran University of Medical Science, Qods Street, Keshavarz Boulevard, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)