SH T00186 in the Treatment of Primary Dysmenorrhea

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT00569244

Collaborator

(none)

223

Enrollment

Locations

Arms

Duration (Months)

8.3

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Primary Dysmenorrhea	Drug: Drug: YAZ flex (SH T00186D) Drug: YAZ (SH T00186D)	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

223 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Dec 1, 2007

Actual Primary Completion Date :

Dec 1, 2009

Actual Study Completion Date :

Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1	Drug: Drug: YAZ flex (SH T00186D) Extended flexible regimen of YAZ (SH T00186D); triggered by bleeding events(Tablet p.o. (oral))
Active Comparator: Arm 2	Drug: YAZ (SH T00186D) YAZ (SH T 00186D) administered in the conventional regimen (24 days active + 4 days placebo) (Tablet p.o. (oral))

Arm

Intervention/Treatment

Experimental: Arm 1

Drug: Drug: YAZ flex (SH T00186D)

Extended flexible regimen of YAZ (SH T00186D); triggered by bleeding events(Tablet p.o. (oral))

Active Comparator: Arm 2

Drug: YAZ (SH T00186D)

YAZ (SH T 00186D) administered in the conventional regimen (24 days active + 4 days placebo) (Tablet p.o. (oral))

Outcome Measures

Primary Outcome Measures

Number of days with dysmenorrheic pain [140 days]

Secondary Outcome Measures

Use of rescue medication [140 days]
Interference with daily activity [140 days]
Number of days: with at least moderate dysmenorrheic pain [140 days]
Number of days with pelvic pain [140 days]
Number of days with dysmenorrheic pain associated with withdrawal bleeding [140 days]
Number of days with dysmenorrheic pain associated with unscheduled bleeding [140 days]
Bleeding patterns [Whole treatment period]
Assessment of treatment [Whole treatment period]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	Heidelberg	Baden-Württemberg	Germany	69120
2	Nürnberg	Bayern	Germany	90491
3	Frankfurt	Hessen	Germany	60439
4	Fulda	Hessen	Germany	36037
5	Mühlheim	Hessen	Germany	63165
6	Hannover	Niedersachsen	Germany	30159
7	Hannover	Niedersachsen	Germany	30459
8	Bernburg	Sachsen-Anhalt	Germany	06406
9	Blankenburg	Sachsen-Anhalt	Germany	38889
10	Burg	Sachsen-Anhalt	Germany	39288
11	Jessen	Sachsen-Anhalt	Germany	06917
12	Magdeburg	Sachsen-Anhalt	Germany	39104
13	Magdeburg	Sachsen-Anhalt	Germany	39126
14	Magdeburg	Sachsen-Anhalt	Germany	39130
15	Leipzig	Sachsen	Germany	04207
16	Leipzig	Sachsen	Germany	04277
17	Leipzig	Sachsen	Germany	04299
18	Wurzen	Sachsen	Germany	04808
19	Gera	Thüringen	Germany	07545
20	Kahla	Thüringen	Germany	07768
21	Berlin		Germany	10247
22	Berlin		Germany	10409
23	Berlin		Germany	12587
24	Berlin		Germany	13086
25	Chesterfield	Derbyshire	United Kingdom	S40 4TF
26	Newcastle Upon Tyne	Tyne and Wear	United Kingdom	NE4 5BE
27	London		United Kingdom	W12 0HS