Leiomyoma of uterus. Leiomyoma of uterus
Conditions
Interventions
Intervention 1: intervention is using microrelin in treatment group. Treatment is started in first 5 days of menstrual cycle by 3.7 mg depot ampule and is repeated for three consecutive cycles. Interv
Treatment - Drugs
intervention is using microrelin in treatment group. Treatment is started in first 5 days of menstrual cycle by 3.7 mg depot ampule and is repeated for three consecutive cycles.
Sponsors
Vice Chancellor for Research of Tehran University of Medical sciences
Eligibility
Sex/Gender
Female
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria: Be a pre-menopausal woman between 18 and 50 years, have indication of surgical myomectomy due to any complain, Less than 2 myomas with the diameter of 2- 4 Cm which are totally intracavitary or have a myometrial expansion less than 50%, If of childbearing potential the subject must be practicing a non-hormonal method of contraception, BMI = 18 and = 40. Exclusion Criteria: Indication of emergent surgery, history of or current uterine cervical, ovarian or breast cancer, current endometrium atypical hyperplasia or adenocarcinoma, a known severe coagulation disorder, has a history of or current treatment for myoma with a Selective Progesterone Receptor Modulator (SPRM) or a GnRH-agonist, Has a history of or known current osteoporosis, abnormal hepatic function at study entry, a positive pregnancy test at baseline or is nursing or planning a pregnancy during the course of the study, a current (within twelve months) problem with alcohol or drug abuse, is currently enrolled in an investigational drug or device study or has participated in such a study within the last 30 days.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Size of myoma. Timepoint: 12 weeks after microrelin subscription. Method of measurement: sonography. | — |
Secondary
| Measure | Time frame |
|---|---|
| Level of gonadotrophins and estrogen in serum. Timepoint: two and 12 weeks after microrelin subscription. Method of measurement: ELISA.;Surgeon's satisfaction. Timepoint: end of operation. Method of measurement: Visual Assessment Score.;Operation time. Timepoint: end of operation. Method of measurement: surjeon's announcement.;Absorbed fluide volume. Timepoint: end of operation. Method of measurement: fluide gathered in suction subtracted from used fluide. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMina Jafarabadi
Reproductive Health research center
Outcome results
None listed