The aim of this study is to compare the efficacy of mefenamic acid and naproxen in the reduction of heavy menstrual bleeding. Women of reproductive age, who suffer from heavy menstrual bleeding, will be recruited in this randomized placebo-controlled study. Participants, who meet inclusion criteria, will be evaluated for 6 menstrual cycles. During the first 3 control cycles, they will record the amount of bleeding on Pictorial Blood Assessment Chart to confirm their having heavy menstrual bleeding. Then, 120 participants, who consent to receive interventions, will be randomly assigned to receive mefenamic acid, naproxen or placebo. Each group will take tablets four times daily from day 1 to 7 of menstrual cycle. All participants will fill in the Pictorial Blood Assessment Chart during the three intervention cycles. After the 3 intervention cycles the charts will be collected and the effect of each medication on the amount of bleeding will be evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201204241548N14
Registration date:2012-05-05, 1391/02/16
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-05-05, 1391/02/16
Registrant information
Name
Khadijeh Abdali
Name of organization / entity
Fatemeh college of nursing and midwifery, Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 4255
Email address
abdalikh@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy for Research of Shiraz University of Medical Sciences
Expected recruitment start date
2012-06-01, 1391/03/12
Expected recruitment end date
2012-12-30, 1391/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of mefenamic acid and naproxen on the amount of heavy menstrual bleeding in women of reprodcutive age: a placebo-controlled study.
Public title
The effect of mefenamic acid, naproxen and placebo on periodic bleeding in women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria were the followings: a) being between 20 and 45 years old of age; b) normal results for cervical smear test; c) negative history of renal or hepatic impairment, thromboembolic disease, inflammatory bowel disease, peptic or intestinal ulceration, coagulation or fibrinolytic disorders; d) normal results for blood tests (including PT, PTT, BT, TSH); e) not taking any hormones and NSAIDS.
Exclusion criteria included: a) infertility; b) overweight/obesity (BMI>25) or underweight (BMI<18.5); c) polycystic ovaries; d) vaginitis and/or pelvic inflammatory disease (PID); e) uterine polyps and/or fibroids; f) carrying IUD; g) being perimenopausal (increased serum FSH showed being premenopausal).
Age
From 20 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Medical Research Ethics Committee of Shiraz University of Medical Sciences
Street address
Zand St,
City
Shiraz,
Postal code
Approval date
2009-02-20, 1387/12/02
Ethics committee reference number
87-3666
Health conditions studied
1
Description of health condition studied
Heavy menstrual bleeding
ICD-10 code
N92.1
ICD-10 code description
Excessive and frequent menstruation with irregular cycle
Primary outcomes
1
Description
Amount of menstrual bleeding
Timepoint
One month
Method of measurement
Pictorial Blood Assessment Chart
Secondary outcomes
1
Description
Decrease in the amount of menstrual bleeding
Timepoint
one month
Method of measurement
Pictorial Blood Assessment Chart
Intervention groups
1
Description
Participants in the first group will receive tablets containing 250 mg of mefenamic acid four times daily (1000 mg total daily intake)from day 1 to day 7 of each menstrual cycle.
Category
Treatment - Drugs
2
Description
Participants in the second group will receive tablets containing 250 mg of naproxen four times daily (1000 mg total daily intake) from day 1 to day 7 of each menstrual cycle.
Category
Treatment - Drugs
3
Description
Participants in the third group will receive placebo tablets four times daily from day 1 to day 7 of each menstrual cycle.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Zeynabiyeh Hospita,
Full name of responsible person
Street address
City
Shiraz,
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy for Research of Shiraz University of Medical Sciences
Full name of responsible person
Dr Mohammad Hosein Dabbagh Manesh
Street address
Zand St,
City
Shiraz,
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy for Research of Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Fatemeh College of Nursing and Midwifery, Shiraz University of Medical Sciences
Full name of responsible person
Khadijeh Abdali
Position
Master's Degree in Midwifery, Faculty Member
Other areas of specialty/work
Street address
Namazi Square,
City
Shiraz,
Postal code
Phone
+98 71164742528
Fax
Email
abdalikh@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fatemeh College of Nursing and Midwifery, Shiraz University of Medical Sciences
Full name of responsible person
Khadijeh Abdali
Position
Master's Degree in Midwifery, Faculty Member
Other areas of specialty/work
Street address
Namazi Square,
City
Shiraz,
Postal code
Phone
+98 71164742528
Fax
Email
abdalikh@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Khadijeh Abdali
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)