Comparison between the synergistic use of oral contraceptives and fluoxetine vs fluoxetine alone in the management of premenstrual syndrome

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12614001243606
• Date of registration: 27/11/2014
• Prospective Registration: No
• Primary sponsor: Cairo university
• 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
• Date of first enrolment: 05/05/2013
• Target sample size: 210
• Recruitment status: Recruiting
• URL: https://anzctr.org.au/ACTRN12614001243606.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Safety/efficacy;
• Phase: Phase 3

Countries of recruitment

Egypt

Contacts

• Name: Dr AbdelGany Hassan

• Name: Dr AbdelGany Hassan

Key inclusion & exclusion criteria

Inclusion criteria: Age 20-40 years
Premenstrual syndrome
Nulligravida
Exclusion criteria: Diabetes
Hypertension
Liver disease
History of DVT
Allergy to fluoxetine

Age minimum: 20 Years
Age maximum: 40 Years
Gender: Females

Health Condition(s) or Problem(s) studied

Premenstrual syndrome ;
Premenstrual syndrome

Reproductive Health and Childbirth - Menstruation and menopause

Intervention(s)

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

Primary Outcome(s)

Changes in the DRSP score. This will be assessed by comparing the DRSP before starting treatment and that 3 months after starting treatment.[3 months after starting the treatment ]

Secondary Outcome(s)

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.[3 months after starting the treatment
]

Fluoxetine side effects.
Women will be asked to report potential fluoxetine side effects like anorexia, insomnia and drowsiness[3 months after starting the treatment]

Secondary ID(s)

Nil known

Source(s) of Monetary Support

Cairo University

Secondary Sponsor(s)

Cairo university hospitals

Ethics review

Status: Approved
Approval date:
Contact:

Obstetrics and gynecology ethical committee