A multi-center, double-blind, double-dummy, randomized, controlled, parallel-group study to assess efficacy and safety of SH T00658ID compared to SH D593B in the treatment of primary dysmenorrhea - Effect on primary dysmenorrhea

• Register: EUCTR
• Last refreshed on: 1 April 2013
• Main ID: EUCTR2008-005625-11-DE
• Date of registration: 20/04/2009
• Prospective Registration: Yes
• Primary sponsor: Bayer Healthcare AG
• Public title: A multi-center, double-blind, double-dummy, randomized, controlled, parallel-group study to assess efficacy and safety of SH T00658ID compared to SH D593B in the treatment of primary dysmenorrhea - Effect on primary dysmenorrhea
• Scientific title: A multi-center, double-blind, double-dummy, randomized, controlled, parallel-group study to assess efficacy and safety of SH T00658ID compared to SH D593B in the treatment of primary dysmenorrhea - Effect on primary dysmenorrhea
• Date of first enrolment: 08/09/2009
• Target sample size: 580
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-005625-11
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: yes Other trial design description: Double-dummy If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no

Countries of recruitment

Germany, Italy

Key inclusion & exclusion criteria

Inclusion criteria:
1. Signed and dated informed consent of subject. If legally required, signed and dated informed consent from parent or legal representative for subjects considered minors by local legislation.
2. Otherwise healthy female subjects requesting contraception and suffering from primary dysmenorrhea with a sum score for dysmenorrheic pain intensity of = 8 over 2 baseline cycles documented by a prospective self-rated sum pain score
3. Age: 14 – 50 years (inclusive; smokers must not be older than 35 years) at the time point of informed consent
4. Normal cervical smear not requiring further follow-up (a cervical smear has to be taken at the screening visit, or a normal result has to be available that was documented within the last 6 months before the screening visit)
5. Women with cyclic menstrual bleeding, defined by a cycle length between 25 and 35 days and no amenorrheic cycles or cycles without withdrawal bleeding during the last 3 months prior to visit 1.
6. Able to tolerate ibuprofen and willing to use only ibuprofen supplied for the study.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Pregnancy or lactation (delivery, abortion, or lactation within three cycles before the start of treatment)
2. Obesity: body mass index (BMI) > 32 kg/m2
3. Hypersensitivity to any of the study drug ingredients
4. Any diseases or conditions that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study medication (such as but not limited to duodenal ulcers, gastritis, gastrectomy or gastric resection surgery, or renal compromise)
5. Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
6. Any disease or condition that may worsen under hormonal treatment such as: See Section 4.1.2 of the Protocol for details.
7. Undiagnosed abnormal genital bleeding
8. Abuse of alcohol, drugs, or medicines (e.g. laxatives)
9. Other contraceptive methods:
• sterilization
• oral, vaginal or transdermal hormonal contraception during treatment
• intra-uterine devices (IUD) with or without hormone release still in place within
30 days of visit 1
• implants/depots still in place within 30 days of visit 1
• long acting preparations (e.g. depot medroxyprogesterone acetate, monthly
contraceptive injection) within a period of three times the injection interval before
start of treatment.
10. Any medication that could result in excessive accumulation, impaired metabolism, or altered excretion of the study drug or interfere with the conduct of the study or the interpretation of the results such as:
• products containing St. John’s wort (Hypericum perforatum) within 28 days
before start of treatment
• antibiotics within 9 days before start of treatment
• anticoagulants (e.g. heparin, coumarin) within 28 days before start of treatment
• antiepileptics (hydantoin derivatives [e.g. phenytoin] or carboxamide derivatives
[e.g. carbamazepine, oxcarbamazepine], others [e.g. felbamate, topiramate,
keppra, zonisamide, lamotrigine]) within 28 days before start of treatment
• hypnotics and sedatives (e.g. barbiturate derivatives, primidone) within 28 days
before start of treatment
• tuberculostatics (e.g. rifampicin) within 28 days before start of treatment
• oral antimycotics (e.g. griseofulvin, ketoconazole, itraconazole, fluoconazole)
within 28 days before start of treatment (no wash-out period necessary for single
shot treatment)
• virostatic agents (except for topical use, e.g. ritonavir) within 28 days before start
of treatment
• phenylbutazone within 28 days before start of treatment
• additional sex steroids and other drugs impairing ovarian function within 28 days
before start of treatment (for exceptions, long acting drugs and contraceptives
refer to exclusion criterion 10).
- Gonadotropin releasing hormone (GnRH) analogue 3 months depot
within 6 months before start of treatment
- GnRH analogue 1 month depot within 3 months before start of treatment
11. Simultaneous participation in another clinical trial or participation in another clinical trial prior to study entry that might have an impact on the study objectives at the discretion of the investigator
12. Major surgery scheduled for the study period
13. Subject is a dependent person, e.g. a family member or member of the investigator’s staff
14. Inability to cooperate with the study procedures for any reason, including the following examples: language comprehension, psychiatric illness, inability to get to the study site.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: no

Health Condition(s) or Problem(s) studied

Primary dysmenorrhea in women requesting oral contraception
MedDRA version: 9.1 Level: LLT Classification code 10030970 Term: Oral contraception

Intervention(s)

Trade Name: Qlaira
Product Name: SH T00658ID
Product Code: SH T00658EA
Pharmaceutical Form: Tablet
INN or Proposed INN: ESTRADIOL VALERATE
CAS Number: 979328
Current Sponsor code: 5104
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3.0-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Trade Name: Qlaira
Product Name: SH T00658ID
Product Code: SH T00658GA
Pharmaceutical Form: Tablet
INN or Proposed INN: ESTRADIOL VALERATE
CAS Number: 979328
Current Sponsor code: 5104
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.0-
INN or Proposed INN: DIENOGEST
CAS Number: 65928587
Current Sponsor code: 37659
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.0-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Trade Name: Qlaira
Product Name: SH T00658ID
Product Code: SH T00658M
Pharmaceutical Form: Tablet
INN or Proposed INN: ESTRADIOL VALERATE
CAS Number: 979328
Current Sponsor code: 5104
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.0-
INN or Proposed INN: DIENOGEST
CAS Number: 65928587
Current Sponsor code: 37659
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3.0-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Trade Name: Qlaira
Product Name: SH T00658ID
Product Code: SH T00658HA
Pharmaceutical Form: Tablet
INN or Proposed INN: ESTRADIOL VALERATE
CAS Number: 979328
Current Sponsor code: 5104
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1.0-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Trade Name: Miranova
Product Code: SH D593A
Pharmaceutical Form: Tablet
Other descriptive name: ethinylestradiol
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration numbe

Primary Outcome(s)

Primary end point(s): The primary efficacy endpoint is the individual absolute change in days with dysmenorrheic pain from pretreatment (i.e. two baseline cycles). Dysmenorrheic pain is defined as pain during the menstrual/withdrawal bleeding episode and the 2 days before this episode.

Secondary Objective: The secondary objectives of this study are to compare SH T00658ID and SH D593B with regard to
• Score points of dysmenorrheic pain in a defined period, i.e. comparison between 2 baseline cycles and 2 treatment cycles
• Number of days with pelvic pain independent of occurrence of vaginal bleeding (2 baseline vs. 2 treatment cycles)
• Number of days with dysmenorrheic pain during unscheduled bleedings (2 baseline vs. 2 treatment cycles)
• Rescue medication consumption
• Interference of dysmenorrheic pain with work/school and social or other activities
• Absenteeism question, questionnaires: Resource Use Questionnaire, Clinical Global
Impression (CGI) and health and well being questionnaire SF-36 version 1.

Main Objective: The primary objective of this study is to show superiority of SH T00658ID over
SH D593B with respect to the number of days with dysmenorrheic pain in a defined period, i.e. comparison between two baseline cycles and two treatment cycles.

Secondary ID(s)

DC00050/91781