Oral versus vaginal progesterone for treatment of endometrial hypreplasia

A Comparative Study on the Clinical Effects and Side Effects of Oral Progesterone versus Vaginal Progesterone for the Treatment of Endometrial Hyperplasia in Patients with Abnormal Uterine Bleeding (AUB)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20140820018866N8

Enrollment

Registered

2019-11-10

Start date

2019-11-22

Completion date

Unknown

Last updated

2023-02-07

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

Conditions

Endometrial hyperplasia. Endometrial hyperplasia

Interventions

Intervention 1: Intervention group: daily use of 100 mg Actogest vaginal tablets (Atipharmed Pharmaceutical Company) from 10th to 25th day of the menstrual cycle for 3 months. Intervention 2: Control

Eligibility

Sex/Gender

Female

Age

25 Years to 70 Years

Inclusion criteria

Inclusion criteria: Aged between 25 and 70 years old Endometrial hyperplasia without atypia associated with abnormal uterine bleeding

Exclusion criteria

Exclusion criteria: Malignancy Genital infection Contraindication for progesterone use such as Haptic disorders or tumor, thromboembolism, etc. History of hormone therapy during last 6 months

Design outcomes

Primary

Measure	Time frame
Pathological changes in endometrial sample. Timepoint: At baseline (before the interventions began) and three months after interventions began. Method of measurement: Evaluation of endometrial tissue sample by pathologist for evaluation of cellular changes.;Vaginal bleeding. Timepoint: At baseline (before the interventions began) and three months after interventions began. Method of measurement: Number of pads used.;Hemoglobin level. Timepoint: At baseline (before the interventions began) and three months after interventions began. Method of measurement: A complete blood count (CBC).	—

Measure

Time frame

Pathological changes in endometrial sample. Timepoint: At baseline (before the interventions began) and three months after interventions began. Method of measurement: Evaluation of endometrial tissue sample by pathologist for evaluation of cellular changes.;Vaginal bleeding. Timepoint: At baseline (before the interventions began) and three months after interventions began. Method of measurement: Number of pads used.;Hemoglobin level. Timepoint: At baseline (before the interventions began) and three months after interventions began. Method of measurement: A complete blood count (CBC).

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Secondary

Measure	Time frame
Clinical side effects of the drug. Timepoint: At baseline (before the interventions began) and three months after interventions began. Method of measurement: Recording clinical side effects including headache, bruising, bloating, nausea and vomiting, weight gain, joint and muscle pain, gastric pain, vaginal itching, uterine pain, as well as delayed menstruation, irregular bleeding, and clotting in a questionnaire.;Paraclinical side effects of the drug. Timepoint: At baseline (before the interventions began) and three months after interventions began. Method of measurement: Measurement of blood pressure, lipid and glucose profiles, liver function tests and CBC.	—

Measure

Time frame

Clinical side effects of the drug. Timepoint: At baseline (before the interventions began) and three months after interventions began. Method of measurement: Recording clinical side effects including headache, bruising, bloating, nausea and vomiting, weight gain, joint and muscle pain, gastric pain, vaginal itching, uterine pain, as well as delayed menstruation, irregular bleeding, and clotting in a questionnaire.;Paraclinical side effects of the drug. Timepoint: At baseline (before the interventions began) and three months after interventions began. Method of measurement: Measurement of blood pressure, lipid and glucose profiles, liver function tests and CBC.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Zahra Molla amin

Arash women hospital

asalamini64@gmail.com+98 21 7788 3283

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Aug 23, 2026