SH T00186 in the Treatment of Primary Dysmenorrhea

Primary Dysmenorrhea Clinical Trial

Official title:

A Multi-center, Open-label, Randomized, Controlled, Parallel-group Study to Assess Efficacy and Safety of an Extended Flexible Regimen of the Combined Oral Contraceptive SH T00186D (0.02 mg Ethinylestradiol as Beta-cyclodextrin Clathrate and 3 mg Drospirenone) Compared to the Conventional Regimen of SH T00186D in the Treatment of Primary Dysmenorrhea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00569244
• Other study ID #: 91587
• Secondary ID: 2006-004899-1331
• Status: Completed
• Phase: Phase 3
• First received: December 5, 2007
• Last updated: October 28, 2014
• Start date: December 2007
• Est. completion date: December 2009

Study information

• Verified date: October 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

The investigational drug SH T00186D is an oral contraceptive. The investigational drug used in this study contains the estrogen ethinylestradiol (EE) and the progestogen drospirenone (DRSP).

The aim of the present study is to evaluate efficacy and safety of the investigational drug in the treatment of menstrual pain (pelvic pain occurring shortly before, at onset, during menstruation). Two different regimens of intake of the same investigational product will be compared.

Patients have to undergo 2 -3 Baseline cycles (depending on whether the patient was an OC user before), during which menstrual pain, bleeding events, and pain killer intake have to be documented. During this observation period, the intake of hormonal contraceptives is not allowed. Other contraceptive methods (condoms with spermicide, pessary with spermicide) have to be used. If the patient is eligible for the study, she will be randomly assigned to one of the two treatment groups. Treatment group A will take the medication according to an extended flexible regimen, i.e., tablet intake will be triggered by bleeding events. Treatment group B will take the study medication in the 24 + 4 days regimen. That means, tablets to be taken on cycle days 1 - 24 contain the hormone combination, whereas tablets 25

• 28 do not contain any active ingredients, i.e., these are so called placebo tablets.

Treatment will last at least 140 days, but can be prolonged in Treatment Group A depending of occurrence of menstrual bleeding. The overall study duration will be 10 months for each patient.

During the whole study period, 5 visits are planned. At Screening and Final examination, a thorough physical examination and a gynecological examination (including breath palpation and cervical smear ) will be performed. Blood samples will be taken for safety laboratory parameters.

Additional examinations can be performed any time, if this becomes necessary for medical reasons.

Patients will be provided with a patient diary to document the intake of study medication, any bleeding events and days without bleeding, pregnancy test results, any dysmenorrheic (menstrual) pain and its intensity and its interference with daily activity, and intake of pain medication. The pain medication (ibuprofen) will be provided.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 223
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Otherwise healthy female patients with moderate to severe primary dysmenorrhea

• Prospective self-rated sum pain score of >/= 8 during the 2 baseline cycles

• Age between 18 and 40 years (inclusive) with smoking habits as follows:

• between 18 and 30 years of age. daily cigarette consumption not above 10

• above 30 years of age, no smoking

Exclusion Criteria:

• Current signs of history of any forms of secondary dysmenorrhea

• Any concomitant disease of condition that requires any intake of analgesic medication

• Occurrence of less than six menstrual cycles before Visit 1 following delivery, abortion, or lactation

• Clinically significant depression

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dysmenorrhea
• Primary Dysmenorrhea

Intervention

Drug:
• Drug: YAZ flex (SH T00186D)
Extended flexible regimen of YAZ (SH T00186D); triggered by bleeding events(Tablet p.o. (oral))
• YAZ (SH T00186D)
YAZ (SH T 00186D) administered in the conventional regimen (24 days active + 4 days placebo) (Tablet p.o. (oral))

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Germany,  United Kingdom, 

References & Publications (1)

Strowitzki T, Kirsch B, Elliesen J. Efficacy of ethinylestradiol 20 µg/drospirenone 3 mg in a flexible extended regimen in women with moderate-to-severe primary dysmenorrhoea: an open-label, multicentre, randomised, controlled study. J Fam Plann Reprod He — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of days with dysmenorrheic pain		140 days	No
Secondary	Use of rescue medication		140 days	No
Secondary	Interference with daily activity		140 days	No
Secondary	Number of days: with at least moderate dysmenorrheic pain		140 days	No
Secondary	Number of days with pelvic pain		140 days	No
Secondary	Number of days with dysmenorrheic pain associated with withdrawal bleeding		140 days	No
Secondary	Number of days with dysmenorrheic pain associated with unscheduled bleeding		140 days	No
Secondary	Bleeding patterns		Whole treatment period	Yes
Secondary	Assessment of treatment		Whole treatment period	No

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