Pentoxifylline versus progesterone medicated intrauterine device in controlling pain and increased menstrual blood flow of women with adenomyosis

• Register: ANZCTR
• Last refreshed on: 19 November 2018
• Main ID: ACTRN12617001021369
• Date of registration: 14/07/2017
• Prospective Registration: Yes
• Primary sponsor: nahed allam
• Public title: Pentoxifylline versus progesterone medicated intrauterine device in controlling pain and increased menstrual blood flow of women with adenomyosis
• Scientific title: Progesterone impregnated IUD versus pentoxifylline in management of women with symptomatic adenomyosis
• Date of first enrolment: 10/09/2018
• Target sample size: 70
• Recruitment status: Recruiting
• URL: https://anzctr.org.au/ACTRN12617001021369.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Safety/efficacy;
• Phase: Phase 3

Countries of recruitment

Egypt

Contacts

• Name: Dr Nahed Ezzat Allam

• Name: Dr Taiseer Maarouf

Key inclusion & exclusion criteria

Inclusion criteria: Women with symptomatic adenomyosis (menstrual irregularities –pain-subfertility):
1- Age more 30 years and less than 50.
2- Patients not seeking for fertility.
3- Patients were seeking an alternative to hysterectomy

Exclusion criteria: 1. Uterine fundal level more than 20cm above symphysis pubis
2. Active pelvic infection or current use of contraceptive
3. Contraindication for medications



Age minimum: 30 Years
Age maximum: 50 Years
Gender: Females

Health Condition(s) or Problem(s) studied

Reproductive Health and Childbirth - Other reproductive health and childbirth disorders

dysmenorrhea;chronic pelvic pain;menorrhagia;adenomyosis;
dysmenorrhea
chronic pelvic pain
menorrhagia
adenomyosis

Intervention(s)

Levonorgestrel medicated intrauterine device contain 52 mg of levonorgestrel , will be inserted by consultant ,as simple outpatient procedure . progestin provide a release rate of approximately 20mcg/day. It still reactive for five years, patient adherence checked one month then three months after insertion and every one year visit.

Primary Outcome(s)

chronic pelvic pain,measured by visual analogue score
chronic pelvic pain means pain at lower abdominal pain last for six months or more.[baseline and 3 months post treatment commencement]

dysmenorrhea pain measured by visual analogue score[baseline and 3 months post treatment commencement]

Secondary Outcome(s)

uterine volume measured by transvaginal ultrasound
measured in cubic cm [baseline and 3 months post treatment commencement]

menorrhagia,measured by hemoglobin deficit
hemoglobin deficit calculated by subtraction of baseline haemoglobin in grams from hemoglobin level 3 months post treatment commencement.[ baseline and 3 months post treatment commencement]

volume of localized adenomyosis,measured by transvaginal ultrasound
volume measured in cubic cm [3 months]

metrorrhagia
its uterine bleeding at irregular periods (yes or no catigorical variable)[baseline and 3 months post treatment commencement]

numberof localized adenomyosis,measured by transvaginal ultrasound
[baseline and 3 months post treatment commencement]

Secondary ID(s)

none

Source(s) of Monetary Support

alzahraa university hospital

Ethics review

Status: Approved
Approval date:
Contact:

Ethical and Research and approval by local ethical committee of OB/ Gyn department -AlAzhar university