Clinical Trials List
Protocol NumberBAY 86-5027 / 91773
NCT Number(ClinicalTrials.gov Identfier)NCT01638910
2012-06-29 - 2014-11-28
Phase III
Terminated6
ICD-10Z30.011
Encounter for initial prescription of contraceptive pills
ICD-10Z30.012
Encounter for prescription of emergency contraception
ICD-9V25.01
General counseling and advice of prescription of oral contraceptives
A multi-center, open, uncontrolled phase 3 study to investigate the efficacy and safety of a 4-phasic oral contraceptive SH T00658ID containing estradiol valerate and dienogest in a 28-day regimen for 13 cycles in healthy female subjects
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Trial Applicant
BAYER TAIWAN COMPANY LTD.
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Sponsor
-
Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- 華筱玲 Division of Obstetrics & Gynecology
- MEI-JOU CHEN Division of Obstetrics & Gynecology
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- Hsing-Tse Yu Division of Obstetrics & Gynecology
- Hsin-Shih Wang Division of Obstetrics & Gynecology
- Chin-Jung Wang Division of Obstetrics & Gynecology
The Actual Total Number of Participants Enrolled
0 Completed
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- YU-CHIAO YI Division of Obstetrics & Gynecology
- 何彥秉 Division of Obstetrics & Gynecology
- 陳明哲 Division of Obstetrics & Gynecology
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- 郭昱伶 Division of Obstetrics & Gynecology
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Completed
Condition/Disease
oral contraceptive
Objectives
This study will investigate the contraceptive efficacy, cycle control, and
bleeding pattern, and the safety of SH T00658ID in approximately 940 women
aged 18 to 50 years
Test Drug
BAY 86-5027
Active Ingredient
Estradiol Valerate (EV) / Dienogest (DNG)
Dosage Form
tablet
Dosage
3.0 mg /2 days
2.0 mg EV+2.0 mg DNG/ 5 days
2.0 mg EV+2.0 mg DNG/ 5 days
Endpoints
The efficacy variables for this study are as follows:
number of unintended pregnancies as measured by the PI
analysis of cycle control and bleeding pattern from admission to the study until
Cycle 13
number of unintended pregnancies as measured by the PI
analysis of cycle control and bleeding pattern from admission to the study until
Cycle 13
Inclution Criteria
A subject may be included in the study only if all of the following criteria are met:
1. Signed and dated informed consent, either by the subject or impartial witness, in case
the subject is temporarily not able to sign, e.g., due to a broken hand.15
2. Healthy female subject requesting contraception.
3. Age between 18 and 50 years (inclusive). Smokers must not be older than 35 years at
the time of informed consent.
4. Normal or clinically insignificant cervical smear not requiring further follow-up (a
cervical smear must be obtained at the screening visit or a normal result must be
documented within the previous 6 months). Human papilloma virus (HPV) testing in
subjects with atypical cells of undetermined significance (ASCUS) may be used as an
adjunctive test. Subjects with ASCUS may be included if they are negative for
high-risk HPV strains.16
5. History of regular cyclic menstrual periods without hormonal contraceptive use
1. Signed and dated informed consent, either by the subject or impartial witness, in case
the subject is temporarily not able to sign, e.g., due to a broken hand.15
2. Healthy female subject requesting contraception.
3. Age between 18 and 50 years (inclusive). Smokers must not be older than 35 years at
the time of informed consent.
4. Normal or clinically insignificant cervical smear not requiring further follow-up (a
cervical smear must be obtained at the screening visit or a normal result must be
documented within the previous 6 months). Human papilloma virus (HPV) testing in
subjects with atypical cells of undetermined significance (ASCUS) may be used as an
adjunctive test. Subjects with ASCUS may be included if they are negative for
high-risk HPV strains.16
5. History of regular cyclic menstrual periods without hormonal contraceptive use
Exclusion Criteria
The exclusion criteria refer to known or suspected conditions and are chosen to ensure
that subjects with specific risks for administration of the study drugs, or subjects with
conditions which may have an impact on the aims of the study are excluded.
1. Pregnancy or lactation (less than three months since delivery, abortion, or lactation
before start of treatment)
2. Body mass index17 (BMI) >32 kg/m2
3. Hypersensitivity to any ingredient of the study drug
4. Laboratory values outside inclusion range before allocation of treatment
5. Any disease or condition 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)
6. Any disease or condition that might interfere with the conduct of the study or the
interpretation of the results
7. Any disease or condition that may worsen under hormonal treatment according to the
assessment and opinion of the investigator. The following are examples of such
conditions or diseases:
Cardiovascular
presence or a history of venous or arterial thrombotic / thromboembolic events (e.g.,
deep venous thrombosis, pulmonary embolism, myocardial infarction) or of a
cerebrovascular accident, including prodromi (e.g., transient ischemic attack, angina
pectoris) and conditions which could increase the risk of suffering from any of the
above mentioned disorders, e.g., a family history indicating a hereditary
predisposition repeated measurements of systolic blood pressure >140 mmHg and/or
diastolic blood
pressure >90 mmHg
Liver
presence or history of liver tumors (benign or malignant)
presence or history of severe hepatic disease, where liver function parameter values
have not returned to normal
jaundice and / or pruritus related to cholestasis (except Gilbert’s syndrome)
history of cholestatic jaundice associated with pregnancy or previous COC use
Metabolic diseases
uncontrolled diabetes mellitus and/or diabetes mellitus with vascular involvement
severe dyslipoproteinemia
Other diseases
malignant or premalignant disease
uncontrolled thyroid disorder
chronic inflammatory bowel disease
severe renal insufficiency or acute renal failure
hemolytic uremic syndrome
sickle cell anemia
porphyria
history of hypertriglyceridemia-associated pancreatitis
systemic lupus erythematosus, pemphigoid gestationis during a previous pregnancy
Sydenham chorea
history of herpes gestationis
otosclerosis-related hearing loss
history of migraine with focal neurologic symptoms
epilepsy
clinically significant depression
hereditary angioedema
8. Undiagnosed abnormal genital bleeding
9. Abuse of alcohol, drugs, or medicines (e.g., laxatives)
10. Other contraceptive methods:
sterilization
long-acting preparations (e.g., depot- medroxyprogesterone acetate, monthly
contraceptive injection) within a period of 3 times of the injection interval before start
of treatment. The use of non-study oral, vaginal, or transdermal hormonal
contraception, intrauterine devices (IUDs) with or without hormonal release, and
implants (still in place within 30 days of Visit 1) are prohibited during treatment.
11. Any medication that could result in excessive accumulation, impaired metabolism,
altered excretion of the study drug, or that might 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]) 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 #9)18
o gonadotropin releasing hormone analog 3 months depot within 6 months before
start of treatment
o gonadotropin releasing hormone analog 1 month depot within 3 months before
start of treatment
12. Simultaneous participation in another clinical trial. Participation in another clinical
trial prior to study entry that might have an impact on the study objectives at the
discretion of the investigator
13. Major surgery scheduled for the study period
14. Close affiliation with the investigational site; e.g., a close relative of the investigator,
dependent person (e.g., employee or student of investigational site; or sponsor’s staff)
15. 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.
that subjects with specific risks for administration of the study drugs, or subjects with
conditions which may have an impact on the aims of the study are excluded.
1. Pregnancy or lactation (less than three months since delivery, abortion, or lactation
before start of treatment)
2. Body mass index17 (BMI) >32 kg/m2
3. Hypersensitivity to any ingredient of the study drug
4. Laboratory values outside inclusion range before allocation of treatment
5. Any disease or condition 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)
6. Any disease or condition that might interfere with the conduct of the study or the
interpretation of the results
7. Any disease or condition that may worsen under hormonal treatment according to the
assessment and opinion of the investigator. The following are examples of such
conditions or diseases:
Cardiovascular
presence or a history of venous or arterial thrombotic / thromboembolic events (e.g.,
deep venous thrombosis, pulmonary embolism, myocardial infarction) or of a
cerebrovascular accident, including prodromi (e.g., transient ischemic attack, angina
pectoris) and conditions which could increase the risk of suffering from any of the
above mentioned disorders, e.g., a family history indicating a hereditary
predisposition repeated measurements of systolic blood pressure >140 mmHg and/or
diastolic blood
pressure >90 mmHg
Liver
presence or history of liver tumors (benign or malignant)
presence or history of severe hepatic disease, where liver function parameter values
have not returned to normal
jaundice and / or pruritus related to cholestasis (except Gilbert’s syndrome)
history of cholestatic jaundice associated with pregnancy or previous COC use
Metabolic diseases
uncontrolled diabetes mellitus and/or diabetes mellitus with vascular involvement
severe dyslipoproteinemia
Other diseases
malignant or premalignant disease
uncontrolled thyroid disorder
chronic inflammatory bowel disease
severe renal insufficiency or acute renal failure
hemolytic uremic syndrome
sickle cell anemia
porphyria
history of hypertriglyceridemia-associated pancreatitis
systemic lupus erythematosus, pemphigoid gestationis during a previous pregnancy
Sydenham chorea
history of herpes gestationis
otosclerosis-related hearing loss
history of migraine with focal neurologic symptoms
epilepsy
clinically significant depression
hereditary angioedema
8. Undiagnosed abnormal genital bleeding
9. Abuse of alcohol, drugs, or medicines (e.g., laxatives)
10. Other contraceptive methods:
sterilization
long-acting preparations (e.g., depot- medroxyprogesterone acetate, monthly
contraceptive injection) within a period of 3 times of the injection interval before start
of treatment. The use of non-study oral, vaginal, or transdermal hormonal
contraception, intrauterine devices (IUDs) with or without hormonal release, and
implants (still in place within 30 days of Visit 1) are prohibited during treatment.
11. Any medication that could result in excessive accumulation, impaired metabolism,
altered excretion of the study drug, or that might 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]) 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 #9)18
o gonadotropin releasing hormone analog 3 months depot within 6 months before
start of treatment
o gonadotropin releasing hormone analog 1 month depot within 3 months before
start of treatment
12. Simultaneous participation in another clinical trial. Participation in another clinical
trial prior to study entry that might have an impact on the study objectives at the
discretion of the investigator
13. Major surgery scheduled for the study period
14. Close affiliation with the investigational site; e.g., a close relative of the investigator,
dependent person (e.g., employee or student of investigational site; or sponsor’s staff)
15. 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.
The Estimated Number of Participants
-
Taiwan
125 participants
-
Global
1200 participants
