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

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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12614001243606
Enrollment
210
Registered
2014-11-27
Start date
2013-05-05
Completion date
2015-01-05
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 orall

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

Sponsors

Cairo university
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)

Eligibility

Sex/Gender
All
Age
20 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

Age 20-40 years Premenstrual syndrome Nulligravida

Exclusion criteria

Diabetes Hypertension Liver disease History of DVT Allergy to fluoxetine

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026