Clinical Trials List
Protocol NumberCLEE011E2301
NCT Number(ClinicalTrials.gov Identfier)NCT02278120
2015-01-15 - 2023-06-06
Phase III
Terminated8
ICD-10C50.919
Malignant neoplasm of unspecified site of unspecified female breast
A Phase III randomized, double-blind, placebo-controlled study of LEE011 or placebo in combination with tamoxifen and goserelin or a non-steroidal aromatase inhibitor (NSAI) and goserelin for the treatment of premenopausal women with hormone receptor positive, HER2-negative, advanced breast cancer.
-
Trial Applicant
NOVARTIS (TAIWAN) CO., LTD.
-
Sponsor
Novartis Pharmaceuticals
-
Trial scale
Multi-Regional Multi-Center
-
Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Wen-Chi Shen Division of Hematology & Oncology
- 沈士哲 Division of General Surgery
- Chi-Chang Yu Division of General Surgery
- Yung-Chang Lin Division of Hematology & Oncology
- 張潤忠 Division of Radiology
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- Yu-Li Su Division of Hematology & Oncology
- 吳佳哲 無
- Tai-Jan Chiu Division of Hematology & Oncology
- 陳彥仰 Division of Hematology & Oncology
- Shau-Hsuan Li Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Completed
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- 李芳 Division of General Surgery
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- Jane Wang Division of General Surgery
- 金光亮 Division of General Surgery
- Yi-Fang Tsai Division of General Surgery
- Chun-Yu Liu Division of General Surgery
- Ta-Chung Chao Division of General Surgery
- 邱仁輝 Division of General Surgery
The Actual Total Number of Participants Enrolled
0 Completed
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- SUNG-HSIN KUO Division of Hematology & Oncology
- JHE-CYUAN GUO 無
- 林季宏 無
- Wei-Wu Chen Division of Hematology & Oncology
- 林璟宏 未分科
- 張端瑩 Division of Hematology & Oncology
- Chiun-Sheng Huang 無
- Ann-Lii Cheng 無
- MING-YANG WANG Division of Hematology & Oncology
- WEI-LI MA 無
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- Wei-Hwa Lee Division of Hematology & Oncology
- Yao-Yu Hsieh Division of Hematology & Oncology
- 蘇勇誠 Division of Hematology & Oncology
- Tsu-Yi Chao Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
hormone receptor positive, HER2-negative, advanced breast cancer.
Objectives
Primary Objective
To determine whether treatment with tamoxifen or a NSAI + goserelin + LEE011
prolongs PFS compared to treatment with tamoxifen or a NSAI + goserelin +
placebo in premenopausal women with HR+, HER2-negative advanced breast
cancer.
Secondary Objectives
Key Secondary:
To determine whether treatment with tamoxifen or a NSAI + goserelin + LEE011
prolongs overall survival (OS) compared to treatment with tamoxifen or a NSAI +
goserelin + placebo in premenopausal women with HR+, HER2-negative advanced
breast cancer
Test Drug
LEE011
Active Ingredient
LEE011
Dosage Form
capsule
Dosage
200
Endpoints
Efficacy assessments
CT/ MRI every 8 weeks for the first 18 months, then every 12 weeks thereafter
until disease progression, death, withdrawal of consent, loss to follow-up, or
subject/guardian decision.
Brain CT or MRI as clinically indicated.
Whole body scan as clinically indicated.
Bone x-ray, CT or MRI (if bone lesion at screening) every 8 weeks for the first
18 months and then every 12 weeks thereafter.
Skin color photography (if skin lesions at screening) every 8 weeks during the
first 18 months and then every 12 weeks thereafter.
CT/ MRI for any disease outside of the chest, abdomen, pelvis (if lesion
identified at baseline) every 8 weeks for the first 18 months and then every 12
weeks thereafter.
Survival status every 12 weeks (or earlier if required) regardless of treatment
discontinuation reason.
Safety assessments
Physical examinations
ECOG performance status
Height, weight, and vital signs
12 lead ECGs
ECHO, MUGA scan
Laboratory assessments including hematology, biochemistry, lipid panel,
thyroid function, coagulation (via INR), pregnancy and urinalysis
CT/ MRI every 8 weeks for the first 18 months, then every 12 weeks thereafter
until disease progression, death, withdrawal of consent, loss to follow-up, or
subject/guardian decision.
Brain CT or MRI as clinically indicated.
Whole body scan as clinically indicated.
Bone x-ray, CT or MRI (if bone lesion at screening) every 8 weeks for the first
18 months and then every 12 weeks thereafter.
Skin color photography (if skin lesions at screening) every 8 weeks during the
first 18 months and then every 12 weeks thereafter.
CT/ MRI for any disease outside of the chest, abdomen, pelvis (if lesion
identified at baseline) every 8 weeks for the first 18 months and then every 12
weeks thereafter.
Survival status every 12 weeks (or earlier if required) regardless of treatment
discontinuation reason.
Safety assessments
Physical examinations
ECOG performance status
Height, weight, and vital signs
12 lead ECGs
ECHO, MUGA scan
Laboratory assessments including hematology, biochemistry, lipid panel,
thyroid function, coagulation (via INR), pregnancy and urinalysis
Inclution Criteria
1. Patient is an adult, female ≥ 18 years old and < 60 years old at the time of
informed consent and has signed informed consent before any trial related
activities are conducted and according to local guidelines.
2. Confirmed negative serum pregnancy test (β-hCG) within 72 hrs before starting
study treatment.
3. Patient is premenopausal or perimenopausal at the time of study entry.
Premenopausal status is defined as either:
Patient had last menstrual period within the last 12 months,
OR
If on tamoxifen within the past 14 days, plasma estradiol must be ≥10
pg/mL and FSH ≤40 IU/l or in the premenopausal range, according to
central laboratory definition,
OR
In case of therapy induced amenorrhea, with a plasma estradiol ≥10
pg/mL and/or FSH ≤40 IU/l or in the premenopausal range according
to central laboratory definition.
Patients who have undergone bilateral oophorectomy are not eligible.
Perimenopausal status is defined as neither premenopausal nor
postmenopausal (see exclusion criteria 3).
4. Patient has advanced (locoregionally recurrent or metastatic) breast cancer not
amenable to curative therapy (e.g. surgery and/or radiotherapy).
5. Patients who received (neo) adjuvant therapy for breast cancer are eligible:
If the patient has never received any prior endocrine therapy OR if ≥ 12
months have elapsed since the patient’s last dose of adjuvant therapy,
then the patient is eligible to receive tamoxifen + goserelin or a NSAI +
goserelin for advanced breast cancer based on the investigator’s choice.
If tamoxifen was the last prior (neo) adjuvant therapy and the last dose
was given < 12 months prior to randomization, then the patient is eligible to
receive a NSAI (letrozole or anastrozole) + goserelin for advanced breast
cancer.
If letrozole, anastrozole, fulvestrant, or exemestane was the last prior (neo)
adjuvant therapy and the last dose was given < 12 months prior to
randomization, then the patient is eligible to receive tamoxifen + goserelin
for advanced breast cancer.
Note: Prior (neo) adjuvant anti-cancer therapy must be stopped at least 5 halflives or 7 days before randomization, whichever is longer.
6. Patients who received ≤ 14 days of tamoxifen or a NSAI (letrozole or
anastrozole) with or without goserelin for advanced breast cancer prior to
randomization are eligible. Patients must continue treatment with the same
hormonal agent + goserelin during the study. No treatment interruption is
required for these patients prior to randomization.
7. Patients who have received up to 1 line of chemotherapy for advanced breast
cancer and have been discontinued 28 days before randomization are eligible.
8. Patient has a histologically and/or cytologically confirmed diagnosis of
estrogen-receptor positive and/or progesterone receptor positive breast cancer
by local laboratory (based on most recently analyzed biopsy).
9. Patient has HER2-negative breast cancer (based on most recently analyzed
biopsy) defined as a negative in situ hybridization test or an IHC status of 0,
1+ or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH)
test is required by local laboratory testing.
10. Patient must have either:
Measurable disease, i.e., at least one measurable lesion as per RECIST
1.1 criteria.
OR
If no measurable disease is present, then at least one predominantly lytic
bone lesion must be present (patients with no measurable disease and
only one predominantly lytic bone lesion that has been previously
irradiated are eligible if there is documented evidence of disease
progression of the bone lesion after irradiation).
11. Patient has ECOG PS 0 or 1.
12. Patient has adequate bone marrow and organ function as defined by the
following laboratory values (as assessed by central laboratory):
Absolute neutrophil count ≥ 1.5 × 109
/L.
Platelets ≥ 100 × 109
/L.
Hemoglobin ≥ 9.0 g/dL.
Potassium, sodium, calcium (corrected for serum albumin), magnesium,
and phosphorus within normal limits of the central laboratory.
INR ≤1.5.
Serum creatinine within normal limits of the central laboratory.
In absence of liver metastases, alanine aminotransferase (ALT) and
aspartate aminotransferase (AST) should be below 2.5 × ULN. If the
patient has liver metastases, ALT and AST should be < 5 × ULN.
Total serum bilirubin < ULN; or total bilirubin ≤ 3.0 × ULN with direct
bilirubin within normal range of the central laboratory in patients with well
documented Gilbert’s Syndrome
informed consent and has signed informed consent before any trial related
activities are conducted and according to local guidelines.
2. Confirmed negative serum pregnancy test (β-hCG) within 72 hrs before starting
study treatment.
3. Patient is premenopausal or perimenopausal at the time of study entry.
Premenopausal status is defined as either:
Patient had last menstrual period within the last 12 months,
OR
If on tamoxifen within the past 14 days, plasma estradiol must be ≥10
pg/mL and FSH ≤40 IU/l or in the premenopausal range, according to
central laboratory definition,
OR
In case of therapy induced amenorrhea, with a plasma estradiol ≥10
pg/mL and/or FSH ≤40 IU/l or in the premenopausal range according
to central laboratory definition.
Patients who have undergone bilateral oophorectomy are not eligible.
Perimenopausal status is defined as neither premenopausal nor
postmenopausal (see exclusion criteria 3).
4. Patient has advanced (locoregionally recurrent or metastatic) breast cancer not
amenable to curative therapy (e.g. surgery and/or radiotherapy).
5. Patients who received (neo) adjuvant therapy for breast cancer are eligible:
If the patient has never received any prior endocrine therapy OR if ≥ 12
months have elapsed since the patient’s last dose of adjuvant therapy,
then the patient is eligible to receive tamoxifen + goserelin or a NSAI +
goserelin for advanced breast cancer based on the investigator’s choice.
If tamoxifen was the last prior (neo) adjuvant therapy and the last dose
was given < 12 months prior to randomization, then the patient is eligible to
receive a NSAI (letrozole or anastrozole) + goserelin for advanced breast
cancer.
If letrozole, anastrozole, fulvestrant, or exemestane was the last prior (neo)
adjuvant therapy and the last dose was given < 12 months prior to
randomization, then the patient is eligible to receive tamoxifen + goserelin
for advanced breast cancer.
Note: Prior (neo) adjuvant anti-cancer therapy must be stopped at least 5 halflives or 7 days before randomization, whichever is longer.
6. Patients who received ≤ 14 days of tamoxifen or a NSAI (letrozole or
anastrozole) with or without goserelin for advanced breast cancer prior to
randomization are eligible. Patients must continue treatment with the same
hormonal agent + goserelin during the study. No treatment interruption is
required for these patients prior to randomization.
7. Patients who have received up to 1 line of chemotherapy for advanced breast
cancer and have been discontinued 28 days before randomization are eligible.
8. Patient has a histologically and/or cytologically confirmed diagnosis of
estrogen-receptor positive and/or progesterone receptor positive breast cancer
by local laboratory (based on most recently analyzed biopsy).
9. Patient has HER2-negative breast cancer (based on most recently analyzed
biopsy) defined as a negative in situ hybridization test or an IHC status of 0,
1+ or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH)
test is required by local laboratory testing.
10. Patient must have either:
Measurable disease, i.e., at least one measurable lesion as per RECIST
1.1 criteria.
OR
If no measurable disease is present, then at least one predominantly lytic
bone lesion must be present (patients with no measurable disease and
only one predominantly lytic bone lesion that has been previously
irradiated are eligible if there is documented evidence of disease
progression of the bone lesion after irradiation).
11. Patient has ECOG PS 0 or 1.
12. Patient has adequate bone marrow and organ function as defined by the
following laboratory values (as assessed by central laboratory):
Absolute neutrophil count ≥ 1.5 × 109
/L.
Platelets ≥ 100 × 109
/L.
Hemoglobin ≥ 9.0 g/dL.
Potassium, sodium, calcium (corrected for serum albumin), magnesium,
and phosphorus within normal limits of the central laboratory.
INR ≤1.5.
Serum creatinine within normal limits of the central laboratory.
In absence of liver metastases, alanine aminotransferase (ALT) and
aspartate aminotransferase (AST) should be below 2.5 × ULN. If the
patient has liver metastases, ALT and AST should be < 5 × ULN.
Total serum bilirubin < ULN; or total bilirubin ≤ 3.0 × ULN with direct
bilirubin within normal range of the central laboratory in patients with well
documented Gilbert’s Syndrome
Exclusion Criteria
1. Patient who has received a prior CDK4/6 inhibitor.
2. Patient has a known hypersensitivity to any of the excipients of LEE011 or
goserelin or hormonal treatment assigned (tamoxifen or a NSAI (letrozole or
anastrozole)).
3. Patient is postmenopausal. Postmenopausal status is defined either by:
Prior bilateral oophorectomy
OR
Age ≥60
OR
Age <60 and amenorrhea for 12 or more months (in the absence of
chemotherapy, tamoxifen, toremifene, or ovarian suppression) and FSH
and estradiol in the postmenopausal range per central laboratory normal
range.
If taking tamoxifen or toremifene, and age <60, then FSH and plasma
estradiol level in postmenopausal ranges per central laboratory normal
range.
Note: For women with therapy-induced amenorrhea, serial measurements of
FSH and/or estradiol are needed to ensure postmenopausal status (NCCN
Guidelines Version 3.2014).
4. Patients who currently have inflammatory breast cancer at screening.
5. Patients who received any prior hormonal anti-cancer therapy for advanced
breast cancer, except for ≤ 14 days of tamoxifen or NSAI ± goserelin for
advanced breast cancer prior to randomization.
6. Patient who has not had resolution of all acute toxic effects of prior anti-cancer
therapy to NCI CTCAE version 4.03 Grade ≤1 (except alopecia or other
toxicities not considered a safety risk for the patient at investigator's
discretion).
7. Patient has a concurrent malignancy or malignancy within 3 years of
randomization, with the exception of adequately treated basal cell skin
carcinoma, squamous cell skin carcinoma, non-melanomatous skin cancer or
curatively resected cervical cancer.
8. Patient with CNS metastases.
9. Patient has impairment of gastrointestinal (GI) function or GI disease that may
significantly alter the absorption of the study drugs (e.g., ulcerative diseases
uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small
bowel resection).
10. Patient has a known history of HIV infection (testing not mandatory).
11. Patient has any other concurrent severe and/or uncontrolled medical condition
that would, in the investigator’s judgment, contraindicate patient participation
in the clinical study (e.g., chronic pancreatitis, chronic active hepatitis, etc.).
12. Patient has active cardiac disease or a history of cardiac dysfunction including
any of the following:
History of angina pectoris, symptomatic pericarditis, or myocardial
infarction within 12 months prior to study entry
History of documented congestive heart failure (New York Heart
Association functional classification III-IV)
Documented cardiomyopathy
Patient has a Left Ventricular Ejection Fraction (LVEF) < 50% as
determined by Multiple Gated acquisition (MUGA) scan or echocardiogram
(ECHO)
History of any cardiac arrhythmias, e.g., ventricular, supraventricular, nodal
arrhythmias, or conduction abnormality in the previous 12 months.
On screening, any of the following cardiac parameters: bradycardia (heart
rate < 50 at rest), tachycardia (heart rate > 90 at rest), PR interval > 220
msec, QRS interval >109 msec, or QTcF >450 msec.
Systolic blood pressure >160 or <90 mmHg
13. Patient is currently receiving any of the following substances and cannot be
discontinued 7 days prior to the start of the treatment:
Known strong inducers or inhibitors of CYP3A4/5, including grapefruit,
grapefruit hybrids, pummelos, star-fruit, and Seville oranges.
Medications with a known risk to prolong the QT interval or induce
Torsades de Pointes.
Medications that have a narrow therapeutic window and are predominantly
metabolized through CYP3A4/5.
Known strong inducers or inhibitors of CYP2D6.
Herbal preparations/medications
14. Patient has had major surgery within 14 days prior to starting study drug or has
not recovered from major side effects.
15. Patient is currently receiving warfarin or other Coumadin derived anticoagulant, for treatment, prophylaxis or otherwise. Therapy with heparin, low
molecular weight heparin (LMWH), or fondaparinux is allowed.
16. Patient is currently receiving or has received systemic corticosteroids ≤ 2
weeks prior to starting study drug, or who have not fully recovered from side
effects of such treatment.
Note: The following uses of corticosteroids are permitted: single doses, topical
applications (e.g., for rash), inhaled sprays (e.g., for obstructive airways
diseases), eye drops or local injections (e.g., intra-articular).
17. Patient is concurrently using other antineoplastic agents (except for patients
who are receiving ≤ 14 days of tamoxifen or NSAI ± goserelin for advanced
breast cancer prior to randomization).
18. Patient who has received radiotherapy ≤ 4 weeks or limited field radiation for
palliation ≤ 2 weeks prior to randomization, and who has not recovered to
grade 1 or better from related side effects of such therapy (with the exception
of alopecia) and/or if ≥ 25% of the bone marrow was irradiated.
19. Pregnant or nursing (lactating) women, where pregnancy is defined as the state
of a female after conception and until the termination of gestation, confirmed
by a positive hCG laboratory test.
20. Women of child-bearing potential, defined as all women physiologically capable
of becoming pregnant, unless they are using highly effective methods of
contraception during dosing of study treatment. Highly effective contraception
methods include:
Total abstinence (when this is in line with the preferred and usual lifestyle
of the subject. Periodic abstinence (e.g., calendar, ovulation,
symptothermal, post-ovulation methods) and withdrawal are not
acceptable methods of contraception.
Tubal ligation at least six weeks before taking study treatment.
Male sterilization (at least 6 months prior to screening). For female
subjects on the study, the vasectomized male partner should be the sole
partner for that subject.
Combination of the following:
a. Placement of an intrauterine device (IUD) or intrauterine system (IUS)
b. Barrier methods of contraception: Condom or Occlusive cap
(diaphragm or cervical/vault caps) with spermicidal
foam/gel/film/cream/ vaginal suppository
2. Patient has a known hypersensitivity to any of the excipients of LEE011 or
goserelin or hormonal treatment assigned (tamoxifen or a NSAI (letrozole or
anastrozole)).
3. Patient is postmenopausal. Postmenopausal status is defined either by:
Prior bilateral oophorectomy
OR
Age ≥60
OR
Age <60 and amenorrhea for 12 or more months (in the absence of
chemotherapy, tamoxifen, toremifene, or ovarian suppression) and FSH
and estradiol in the postmenopausal range per central laboratory normal
range.
If taking tamoxifen or toremifene, and age <60, then FSH and plasma
estradiol level in postmenopausal ranges per central laboratory normal
range.
Note: For women with therapy-induced amenorrhea, serial measurements of
FSH and/or estradiol are needed to ensure postmenopausal status (NCCN
Guidelines Version 3.2014).
4. Patients who currently have inflammatory breast cancer at screening.
5. Patients who received any prior hormonal anti-cancer therapy for advanced
breast cancer, except for ≤ 14 days of tamoxifen or NSAI ± goserelin for
advanced breast cancer prior to randomization.
6. Patient who has not had resolution of all acute toxic effects of prior anti-cancer
therapy to NCI CTCAE version 4.03 Grade ≤1 (except alopecia or other
toxicities not considered a safety risk for the patient at investigator's
discretion).
7. Patient has a concurrent malignancy or malignancy within 3 years of
randomization, with the exception of adequately treated basal cell skin
carcinoma, squamous cell skin carcinoma, non-melanomatous skin cancer or
curatively resected cervical cancer.
8. Patient with CNS metastases.
9. Patient has impairment of gastrointestinal (GI) function or GI disease that may
significantly alter the absorption of the study drugs (e.g., ulcerative diseases
uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small
bowel resection).
10. Patient has a known history of HIV infection (testing not mandatory).
11. Patient has any other concurrent severe and/or uncontrolled medical condition
that would, in the investigator’s judgment, contraindicate patient participation
in the clinical study (e.g., chronic pancreatitis, chronic active hepatitis, etc.).
12. Patient has active cardiac disease or a history of cardiac dysfunction including
any of the following:
History of angina pectoris, symptomatic pericarditis, or myocardial
infarction within 12 months prior to study entry
History of documented congestive heart failure (New York Heart
Association functional classification III-IV)
Documented cardiomyopathy
Patient has a Left Ventricular Ejection Fraction (LVEF) < 50% as
determined by Multiple Gated acquisition (MUGA) scan or echocardiogram
(ECHO)
History of any cardiac arrhythmias, e.g., ventricular, supraventricular, nodal
arrhythmias, or conduction abnormality in the previous 12 months.
On screening, any of the following cardiac parameters: bradycardia (heart
rate < 50 at rest), tachycardia (heart rate > 90 at rest), PR interval > 220
msec, QRS interval >109 msec, or QTcF >450 msec.
Systolic blood pressure >160 or <90 mmHg
13. Patient is currently receiving any of the following substances and cannot be
discontinued 7 days prior to the start of the treatment:
Known strong inducers or inhibitors of CYP3A4/5, including grapefruit,
grapefruit hybrids, pummelos, star-fruit, and Seville oranges.
Medications with a known risk to prolong the QT interval or induce
Torsades de Pointes.
Medications that have a narrow therapeutic window and are predominantly
metabolized through CYP3A4/5.
Known strong inducers or inhibitors of CYP2D6.
Herbal preparations/medications
14. Patient has had major surgery within 14 days prior to starting study drug or has
not recovered from major side effects.
15. Patient is currently receiving warfarin or other Coumadin derived anticoagulant, for treatment, prophylaxis or otherwise. Therapy with heparin, low
molecular weight heparin (LMWH), or fondaparinux is allowed.
16. Patient is currently receiving or has received systemic corticosteroids ≤ 2
weeks prior to starting study drug, or who have not fully recovered from side
effects of such treatment.
Note: The following uses of corticosteroids are permitted: single doses, topical
applications (e.g., for rash), inhaled sprays (e.g., for obstructive airways
diseases), eye drops or local injections (e.g., intra-articular).
17. Patient is concurrently using other antineoplastic agents (except for patients
who are receiving ≤ 14 days of tamoxifen or NSAI ± goserelin for advanced
breast cancer prior to randomization).
18. Patient who has received radiotherapy ≤ 4 weeks or limited field radiation for
palliation ≤ 2 weeks prior to randomization, and who has not recovered to
grade 1 or better from related side effects of such therapy (with the exception
of alopecia) and/or if ≥ 25% of the bone marrow was irradiated.
19. Pregnant or nursing (lactating) women, where pregnancy is defined as the state
of a female after conception and until the termination of gestation, confirmed
by a positive hCG laboratory test.
20. Women of child-bearing potential, defined as all women physiologically capable
of becoming pregnant, unless they are using highly effective methods of
contraception during dosing of study treatment. Highly effective contraception
methods include:
Total abstinence (when this is in line with the preferred and usual lifestyle
of the subject. Periodic abstinence (e.g., calendar, ovulation,
symptothermal, post-ovulation methods) and withdrawal are not
acceptable methods of contraception.
Tubal ligation at least six weeks before taking study treatment.
Male sterilization (at least 6 months prior to screening). For female
subjects on the study, the vasectomized male partner should be the sole
partner for that subject.
Combination of the following:
a. Placement of an intrauterine device (IUD) or intrauterine system (IUS)
b. Barrier methods of contraception: Condom or Occlusive cap
(diaphragm or cervical/vault caps) with spermicidal
foam/gel/film/cream/ vaginal suppository
The Estimated Number of Participants
-
Taiwan
42 participants
-
Global
660 participants
