Comparison of Vaginal Estrogen and Evening-primrose Tablets on Transformation Zone Visibility in Unsatisfactory Colposcopy

Determining the effect of vaginal estrogen and evening primrose pill in improving the observation of transformation zone in unsatisfactory colposcopy

A parallel-group, single-blind, randomized, phase 3 clinical trial on 134 patients.

This study will be conducted in Arash Hospital. Patients with unsatisfactory colposcopy are divided into two groups. In the first group: daily conjugated estrogen vaginal cream daily for 3 consecutive weeks vaginally and in The second group: the use of evening primrose tablets in a dose of 1000 mg for 3 consecutive weeks is administered vaginally, after 4 weeks colposcopy is performed again.

Exclusion criteria: 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. Inclusion criteria: Women who are candidates for colposcopy and have an unsatisfactory colposcopy

Intervention groups1: Daily conjugated estrogen vaginal cream (one applicator) vaginally for 3 consecutive weeks Intervention group2: 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

The randomization process will be done using the website www.sealedenvelope.com and in block form. The number of blocks will be 6.

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.