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Trial registered on ANZCTR


Registration number
ACTRN12614001243606
Ethics application status
Approved
Date submitted
12/11/2014
Date registered
27/11/2014
Date last updated
27/11/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison between the synergistic use of oral contraceptives and fluoxetine vs fluoxetine alone in the management of premenstrual syndrome
Scientific title
Comparison between the synergistic use of oral contraceptives and fluoxetine vs fluoxetine alone in the management of premenstrual syndrome
Secondary ID [1] 285642 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Premenstrual syndrome
 293476 0
Condition category
Condition code
Reproductive Health and Childbirth 293761 293761 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
210 women with premenstrual syndrome (PMS) will be prospectively diagnosed. Diagnosis will be done using the daily record of severity of problems (DRSP), women will be asked to fill the diary for 2 months. Only women with 30% increase in the DRSP score in the week before menses in both months will be diagnosed as having PMS.
Women will be randomly divided into 3 groups, group 1 will receive combined oral contraceptives (gynera) tablets, 75mg Gestodene and 0.03mg ethinylestradiol per tablet orally once daily for 21 days starting starting from the second day of menstruation in addition to the continuous use of fluoxetine (Prozac) oral tablets 50mg daily, the second group will receive continuous fluoxetine oral tablets 50mg daily and the third group will receive a placebo daily. Treatment will be continued for 3 months in all the groups. Monitoring of adherence to treatment will be monitored by asking the patients to return the empty tablet strips.Symptoms of premenstrual syndrome will be assesses 3 months after starting the treatment
Intervention code [1] 290582 0
Treatment: Drugs
Comparator / control treatment
Placebo Starch tablets
Control group
Placebo

Outcomes
Primary outcome [1] 293559 0
Changes in the DRSP score. This will be assessed by comparing the DRSP before starting treatment and that 3 months after starting treatment.
Timepoint [1] 293559 0
3 months after starting the treatment
Secondary outcome [1] 311354 0
Side effects of oral contraceptives.
All women will be asked to report potential oral contraceptives side effects like vomiting, headache, intermenstrual bleeding, chloasma, weight gain and breast tenderness.
Timepoint [1] 311354 0
3 months after starting the treatment
Secondary outcome [2] 311501 0
Fluoxetine side effects.
Women will be asked to report potential fluoxetine side effects like anorexia, insomnia and drowsiness
Timepoint [2] 311501 0
3 months after starting the treatment

Eligibility
Key inclusion criteria
Age 20-40 years
Premenstrual syndrome
Nulligravida
Minimum age
20 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Diabetes
Hypertension
Liver disease
History of DVT
Allergy to fluoxetine

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All women with premenstrual syndrome will be invited to participate in the study and asked to sign an informed consent, allocation will be done using sealed envelopes containing computer generated random numbers allocating the patient to a study group
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random numbers
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
single centre randomized, balanced allocation, parallel groups study
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
This is the first study to investigate the role of the synergistic use of oral contraceptives and fluoxetine in premenstrual syndrome according to our knowledge. There are no available data to calculate the sample size. This will be a pilot study and we may suggest further studies with larger sample sizes at the end of the study
Data will be presented in the form of means and standard deviations or frequencies and proportions when appropriate. Categorical data will be compared using ANOVA test and non categorical data will be compared using chi square test or exact test when appropriate

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
5/05/2013
Actual
5/05/2013
Date of last participant enrolment
Anticipated
5/01/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
210
Accrual to date
Final
Recruitment outside Australia
Country [1] 6469 0
Egypt
State/province [1] 6469 0

Funding & Sponsors
Funding source category [1] 290227 0
University
Name [1] 290227 0
Cairo University
Country [1] 290227 0
Egypt
Primary sponsor type
University
Name
Cairo university
Address
1 Alsaraya street
Almanial
Cairo
Egypt
11559
Country
Egypt
Secondary sponsor category [1] 288935 0
Hospital
Name [1] 288935 0
Cairo university hospitals
Address [1] 288935 0
Kasr alainy
1 Alsaraya street
AlManial
Cairo
Egypt
11559
Country [1] 288935 0
Egypt

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291928 0
Obstetrics and gynecology ethical committee
Ethics committee address [1] 291928 0
department of Obs&Gyn
Cairo university hospitals
1 Alsaraya street,
AlManial
Kasr AlAiny
Cairo
Egypt,
11559
Ethics committee country [1] 291928 0
Egypt
Date submitted for ethics approval [1] 291928 0
Approval date [1] 291928 0
01/05/2013
Ethics approval number [1] 291928 0

Summary
Brief summary
210 women with premenstrual syndrome will be randomly divided into 3 groups: group 1 will receive combined oral contraceptives and fluoxetine, group 2 will receive fluoxetine only, and group 3 will receive a placebo.
The change in symptoms will be compared among the groups using DRSP.
Trial website
Trial related presentations / publications
Yonkers KA, Pearlstein TB, Gotman N: A pilot study to compare fluoxetine, calcium And placebo in the management of premenstrual syndrome. J Clin Psychopharmacol. 2013 Oct;33(5):614-20.

Dickerson LM, Mazyck PJ, Hunter MH: premenstrual syndrome.
Am Fam Physician. 2003 Apr 15;67(8):1743-52.

Wichianpitaya J, Taneepanichskul S: A comparative efficacy of Low dose combined oral contraceptives containing desogestrel and Drospirenone in premenstrual symptoms.
Obstet Gynecol Int. 2013;2013:487143
Public notes
DRSP is the main tool used for diagnosis of PMS and comparing groups. DRSP file is attached below.
Attachments [1] 247 247 0 0
/AnzctrAttachments/367407-DRSP.pdf

Contacts
Principal investigator
Name 52686 0
Dr AbdelGany Hassan
Address 52686 0
Cairo university hospitals
Kasr AlAiny
1 Alsaraya street,
AlManial
Cairo
Egypt
11559
Country 52686 0
Egypt
Phone 52686 0
+20 010 17801604
Fax 52686 0
Email 52686 0
[email protected]
Contact person for public queries
Name 52687 0
AbdelGany Hassan
Address 52687 0
Cairo university hospitals
Kasr AlAiny
1 Alsaraya street,
AlManial
Cairo
Egypt
11559
Country 52687 0
Egypt
Phone 52687 0
+20 010 17801604
Fax 52687 0
Email 52687 0
[email protected]
Contact person for scientific queries
Name 52688 0
AbdelGany Hassan
Address 52688 0
Cairo university hospitals
Kasr AlAiny
1 Alsaraya street,
AlManial
Cairo
Egypt
11559
Country 52688 0
Egypt
Phone 52688 0
+20 010 17801604
Fax 52688 0
Email 52688 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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