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 - SH T00186 in the treatment of primary dysmenorrhea
- Conditions
- women suffering from primary dysmenorrheaMedDRA version: 9.1Level: LLTClassification code 10036689Term: Primary dysmenorrhoea
- Registration Number
- EUCTR2006-004899-13-GB
- Lead Sponsor
- Bayer Schering Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 216
1.Medical history of moderate to severe primary dysmenorrhea (i.e., moderate to severe menstruation-related pelvic pain in at least 4 out of 6 preceding cycles)
2.Prospective self-rated sum pain score of >/= 8 over the 2 baseline cycles
3.Age between 18 and 40 years (inclusive) with smoking habits regulated as follows
-Between 18 and 30 years of age, daily cigarette consumption not above 10
-Above 30 years of age, no smoking
4.Non-suspicious cervical smear taken at Visit 1 or within the last 3 months before Visit 1
5.Signed and dated informed consent.
Are the trial subjects under 18? no
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
1.Current signs or history of any forms of secondary dysmenorrhea (e.g., due to underlying endometriosis, fibroids, adenomyosis of the uterus, hematometra)
2.Any concomitant disease or condition that requires any intake of analgesic medication
3.Occurrence of less than six menstrual cycles before Visit 1 following delivery, abortion, or lactation
4.Known hypersensitivity to any ingredient of the study drug and/or rescue medication
5.Any known diseases or conditions that compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study medication
6.Any known severe systemic disease that might interfere with the conduct of the study or the interpretation of the results
7.Known uncontrolled thyroid disorders
8.Clinically significant depression (current or in the last year)
9.Any known abnormal clinically significant findings which, according to the assessment of the investigator, may worsen under hormonal treatment
10.Laboratory values outside inclusion range at Screening
11.Participation in another clinical study or administration of an IMP within 1 month prior to study entry (Visit 1) (or 6 months in case of long-acting progestins)
12.Surgeries scheduled in the study period
13.Known liver diseases:
Previous, acute and chronic progressive liver diseases, e.g., disturbances of bilirubin excretion in the bile (Dubin-Johnson and Rotor syndromes), disturbances of bile secretion, disturbances of bile flow (cholestasis, also a history thereof), idiopathic icterus or pruritus during a former pregnancy or estrogen-progestin treatment
Between the subsidence of a viral hepatitis (normalization of liver parameters) and the beginning of the study there must be an interval of at least 6 months.
Previous or current liver tumors
14.Known vascular diseases:
Existing or previous venous thromboembolic diseases (deep vein thrombosis, pulmonary embolism), existing or previous arterial thromboembolic diseases (myocardial infarction, stroke), as well as any condition increasing the disposition to any of the above, e.g., coagulation disorders with tendency to blood clot formation, hereditary anti-thrombin III deficiency, protein-C and/or protein-S deficiency, any venous thromboembolic event occurred in a sibling or a parent at an early age (Uncontrolled arterial hypertension (confirmed systolic blood pressure > 140 mmHg and/or confirmed diastolic blood pressure > 90 mmHg).
Known diabetes mellitus, impaired glucose tolerance
Known disturbances of lipid metabolism
15.Known sickle-cell anemia
16.Known or suspected malignant or premalignant disease, in particular steroid-hormone dependent malignant or premalignant diseases (e.g., endometrial cancer, ovarian cancer, breast cancer), also a history thereof
17.Known other diseases:
Pemphigoid gestationis during a previous pregnancy, middle-ear deafness (otosclerosis), endometrial hyperplasia, migraine with neurological symptoms (complicated migraine), genital bleeding of unknown origin, manifest kidney disease with impaired renal function, porphyria, past or current uterus myomatosus, worsening of chronic bowel disease (Crohn’s disease or ulcerative colitis) under hormonal treatment
18.Known alcohol, drug, or medicine abuse
19.Prohibited concomi
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method