NCT02427334

Brief Summary

Two hundreds and ten women with premenstrual syndrome will be randomly divided into 3 equal groups using computer generated random numbers. Group 1 will receive oral dienogest (visanne® Bayer, Germany) 2mg for 14 days starting from the 15th day of menstruation, Group 2 will receive fluoxetine (Prozac® Lilly, UK) 20mg and group 3 will receive an oral placebo foe 14 days starting from the 15th day of menstruation.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
210

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2015

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

April 20, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 28, 2015

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

December 1, 2020

Status Verified

November 1, 2020

Enrollment Period

6.7 years

First QC Date

April 20, 2015

Last Update Submit

November 30, 2020

Conditions

Premenstrual Syndrome

Outcome Measures

Primary Outcomes (1)

  • Improvement of DRSP score

    DRSP scores will be documented in each treatment month, the mean score will be compared with the pretreatment score

    Monthly, up to 3 months

Study Arms (3)

Dienogest

ACTIVE COMPARATOR

women will receive oral dienogest 2mg for 14 days starting from the 15th day of menstruation

Drug: Dienogest

Fluoxetine

ACTIVE COMPARATOR

women will receive oral fluoxetine 20mg for 14 days starting from the 15th day of menstruation

Drug: Fluoxetine

Placebo

PLACEBO COMPARATOR

women will receive oral placebo for 14 days starting from the 15th day of menstruation

Drug: Placebo

Interventions

DienogestDRUG

women will receive oral dienogest 2mg for 14 days starting from the 15th day of menstruation

Dienogest
FluoxetineDRUG

women will receive oral fluoxetine 20mg for 14 days starting from the 15th day of menstruation

Fluoxetine
PlaceboDRUG

women will receive oral placebo for 14 days starting from the 15th day of menstruation

Placebo

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • PMS
  • Consents to the procedure

You may not qualify if:

  • Previous medical treatment for PMS
  • Body mass index \> 35 kg/m2
  • Irregular periods
  • Medical disorders like diabetes, hypertension, cardiac, liver, kidney or heart disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo university hospitals

Cairo, Egypt

RECRUITING

Related Publications (3)

  • Lustyk MK, Widman L, Paschane A, Ecker E. Stress, quality of life and physical activity in women with varying degrees of premenstrual symptomatology. Women Health. 2004;39(3):35-44. doi: 10.1300/J013v39n03_03.

    PMID: 15256354BACKGROUND

  • Endicott J, Nee J, Harrison W. Daily Record of Severity of Problems (DRSP): reliability and validity. Arch Womens Ment Health. 2006 Jan;9(1):41-9. doi: 10.1007/s00737-005-0103-y. Epub 2005 Sep 20.

    PMID: 16172836BACKGROUND

  • Smith SS, Gong QH, Hsu FC, Markowitz RS, ffrench-Mullen JM, Li X. GABA(A) receptor alpha4 subunit suppression prevents withdrawal properties of an endogenous steroid. Nature. 1998 Apr 30;392(6679):926-30. doi: 10.1038/31948.

    PMID: 9582073BACKGROUND

MeSH Terms

Conditions

Premenstrual Syndrome

Interventions

dienogestFluoxetine

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic Chemicals

Central Study Contacts

AbdelGany M Hassan

CONTACT

+201017801604abdelgany2@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Gynecology and Obstetrics

Study Record Dates

First Submitted

April 20, 2015

First Posted

April 28, 2015

Study Start

April 1, 2015

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

December 1, 2020

Record last verified: 2020-11

Locations

EG(1)