跳至主要内容
MedPath Trial logoMedPath TrialMedPath Trial Home
临床试验/NCT00754065
NCT00754065已完成3 期

A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Group, 2-arm Study to Show Superiority of the Oral Contraceptive SH T00658ID Over Ortho Tri-Cyclen Lo on Hormone Withdrawal-associated Symptoms After 6 Cycles of Treatment.

Bayer0 个研究点目标入组 409 人开始时间: 2008年9月8日最近更新:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
Bayer
入组人数
409
主要终点
The Change in Average of the 3 Highest Visual Analog Scale (VAS) Values of the Hormone Withdrawal-associated Symptoms Pelvic Pain or Headache During Cycle Days 22 to 28 From Baseline to Cycle 6
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

The objective of the study is to compare the oral contraceptive (OC) SH T00658ID over Ortho Tri-Cyclen Lo administered for 13 cycles to healthy female volunteers between 18 and 50 years of age who request oral contraceptive protection. Subjects on a levonorgestrel (LNG), norgestimate (NGM), norethindrone or norethindrone acetate containing oral contraceptive in a 21-day regimen suffering from hormone withdrawal-associated symptoms such as pelvic pain or headache or both, and willing to continue OC use but to switch to SH T00658ID or Ortho Tri-Cyclen Lo.

详细描述

Safety issues are addressed in the Adverse Events section.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 50 Years（Adult）
性别
Female
接受健康志愿者
是

入选标准

  • •Signed and dated informed consent
  • •Age between 18 and 50 years (inclusive), smokers maximum age of 35 years (inclusive) at Visit 1
  • •Otherwise healthy female subjects requesting contraception and currently using a LNG, NGM, or norethindrone/norethindrone acetate containing OC in a 21-day regimen and suffering from at least moderate pelvic pain, headache or both defined by an average of the highest 3 values of >/=35 mm on a VAS during cycle days 22-28 (35 mm VAS is the expected standard deviation of the population VAS reduction)
  • •Normal or clinically insignificant cervical smear not requiring further follow up (a cervical smear has to be taken at screening visit or a normal result has to be documented within the last 6 months before screening) Women with atypical squamous cell of undetermined significance (ASCUS) can be included if they have a negative human papilloma virus (HPV) test result. The laboratory will perform an HPV test if the Pap smear result is ASCUS.
  • •Able to tolerate ibuprofen and willing to use only ibuprofen supplied by the investigator

排除标准

  • •Pregnancy or lactation (less than three cycles since delivery, abortion, or lactation before start of treatment)
  • •Body mass index (BMI) >32 kg/m2
  • •Hypersensitivity to any of the study drug ingredients
  • •Individuals not willing to consume pork and beef products. Women may be included if they are willing to take the capsules
  • •Safety relevant laboratory values, provided by the central laboratory, outside inclusion range before start of treatment
  • •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)
  • •Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
  • •Any disease or condition that may worsen under hormonal treatment
  • •Undiagnosed abnormal genital bleeding
  • •Abuse of alcohol, drugs, or medicines (eg, laxatives)
  • •Other contraceptive methods
  • •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
  • •Simultaneous participation in another clinical trial prior to study entry that might have an impact on the study objectives at the discretion of the investigator
  • •Major surgery scheduled for the study period
  • •Subject is a dependent person, eg: a family member or member of the Investigator's staff
  • •Inability to cooperate with the study procedures for any reason, including language comprehension, psychiatric illness, inability to get to the study site

研究组 & 干预措施

Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027)

Experimental

Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)

干预措施: Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027) (Drug)

Ortho Tri-Cyclen Lo

Active Comparator

Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)

干预措施: Ortho Tri Cyclen Lo (Drug)

结局指标

主要结局

The Change in Average of the 3 Highest Visual Analog Scale (VAS) Values of the Hormone Withdrawal-associated Symptoms Pelvic Pain or Headache During Cycle Days 22 to 28 From Baseline to Cycle 6

时间窗: Day 22-28 from Baseline to Day 22-28 from Cycle 6 (28 days per Cycle)

Subject self-assessed pelvic pain or headache per visual analog scale (VAS) values during the menstrual/withdrawal bleeding episode and Baseline. The VAS consists of a 100 mm long straight line, with verbal anchors at either end, representing a continuum of pain intensity. Accordingly, the scale ranges from 0 mm (absence of pain) to 100 mm (unbearable pain), and the change ranges from -100 mm (best) to 100 mm (worst).

次要结局

  • The Change From Baseline to Cycle 13 in the Number of Ibuprofen Tablets Used as Rescue Medication(From Baseline to Cycle 13 (28 days per Cycle))
  • Number of Days With Bleeding or Spotting in Reference Period 2(From Day 91 to Day 180)
  • The Change From Baseline to Cycle 6 in the Number of Ibuprofen Tablets Used as Rescue Medication(From Baseline to Cycle 6 (28 days per Cycle))
  • Change From Baseline to Cycle 6 in the Number of Days With at Least Moderate Pain/Intensity of Other Hormone-related Symptoms During Cycle Days 22-28(Day 22-28 from Baseline to Day 22-28 from Cycle 6 (28 days per Cycle))
  • Change From Baseline to Cycle 6 in the Number of Days With at Least Moderate Pain/Intensity of Individual Hormone-related Symptoms During Cycle Days 1-21(Day 1-21 from Baseline to Day 1-21 from Cycle 6 (28 days per Cycle))
  • Change From Baseline to Cycle 13 in the Number of Days With at Least Moderate Pain/Intensity of Individual Hormone-related Symptoms During the Hormone-free Interval Cycle Days 27 to 28 for EV/DNG and Cycle Days 22 to 28 for EE/NGM(From Baseline to Cycle 13 (cycle Days 27 to 28 for EV/DNG and cycle Days 22 to 28 for EE/NGM, 28 days per Cycle))
  • Number of Days With Bleeding or Spotting in Reference Period 4(From Day 271 to Day 360)
  • Number of Bleeding / Spotting Episodes in Reference Period 2(From Day 91 to Day 180)
  • Change From Baseline to Cycle 13 in the Number of Days With at Least Moderate Pain/Intensity of Other Hormone-related Symptoms During Cycle Days 22-28(Day 22-28 from Baseline to Day 22-28 from Cycle 13 (28 days per Cycle))
  • Change From Baseline to Cycle 6 in the Number of Days With at Least Moderate Pain/Intensity of Individual Hormone-related Symptoms During the Hormone-free Interval Cycle Days 27 to 28 for EV/DNG and Cycle Days 22 to 28 for EE/NGM(From Baseline to Cycle 6 (cycle Days 27 to 28 for EV/DNG and cycle Days 22 to 28 for EE/NGM, 28 days per Cycle))
  • Number of Days With Bleeding or Spotting in Reference Period 1(From Day 1 to Day 90)
  • Number of Days With Bleeding or Spotting in Reference Period 3(From Day 181 to Day 270)
  • Change From Baseline to Cycle 13 in the Average of the Three Highest VAS Values of the Hormone Withdrawal-associated Symptoms Pelvic Pain or Headache During Cycle Days 22 to 28(Days 22-28 from Baseline to Days 22-28 from Cycle 13 (28 days per Cycle))
  • Mean Length of Bleeding / Spotting Episodes in Reference Period 3(From Day 181 to Day 270)
  • Maximum Length of Bleeding / Spotting Episodes in Reference Period 2(From Day 91 to Day 180)
  • Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 3(From Day 181 to Day 270)
  • Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 4(From Day 271 to Day 360)
  • Number of Spotting-only Episodes in Reference Period 1(From Day 1 to Day 90)
  • Number of Spotting-only Episodes in Reference Period 3(From Day 181 to Day 270)
  • Mean Length of Spotting-only Episodes in Reference Period 4(From Day 271 to Day 360)
  • Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 1(From Day 1 to Day 90)
  • Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 2(From Day 91 to Day 180)
  • Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 3(From Day 181 to Day 270)
  • Length of Withdrawal Bleeding Episodes at Cycle 1(At Cycle 1 (28 days per Cycle))
  • Change From Baseline to Cycle 13 in the Number of Days With at Least Moderate Pain/Intensity of Individual Hormone-related Symptoms During Cycle Days 1-21(Day 1-21 from Baseline to Day 1-21 from Cycle 13 (28 days per Cycle))
  • Change From Baseline to Cycle 3 in the Average of the Three Highest VAS Values of the Hormone Withdrawal-associated Symptoms Pelvic Pain or Headache During Cycle Days 22 to 28(Days 22-28 from Baseline to Days 22-28 from Cycle 3 (28 days per Cycle))
  • Maximum Length of Bleeding / Spotting Episodes in Reference Period 3(From Day 181 to Day 270)
  • Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 2(From Day 91 to Day 180)
  • Number of Days With Spotting-only in Reference Period 2(From Day 91 to Day 180)
  • Number of Days With Spotting-only in Reference Period 4(From Day 271 to Day 360)
  • Number of Bleeding / Spotting Episodes in Reference Period 3(From Day 181 to Day 270)
  • Mean Length of Bleeding / Spotting Episodes in Reference Period 2(From Day 91 to Day 180)
  • Number of Bleeding / Spotting Episodes in Reference Period 1(From Day 1 to Day 90)
  • Mean Length of Bleeding / Spotting Episodes in Reference Period 4(From Day 271 to Day 360)
  • Maximum Length of Bleeding / Spotting Episodes in Reference Period 4(From Day 271 to Day 360)
  • Maximum Length of Spotting-only Episodes in Reference Period 2(From Day 91 to Day 180)
  • Maximum Length of Spotting-only Episodes in Reference Period 4(From Day 271 to Day 360)
  • Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 4(From Day 271 to Day 360)
  • Length of Withdrawal Bleeding Episodes at Cycle 6(At Cycle 6 (28 days per Cycle))
  • Length of Withdrawal Bleeding Episodes at Cycle 13(At Cycle 13 (28 days per Cycle))
  • Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1(At Cycle 1 (28 days per Cycle))
  • Number of Bleeding / Spotting Episodes in Reference Period 4(From Day 271 to Day 360)
  • Mean Length of Bleeding / Spotting Episodes in Reference Period 1(From Day 1 to Day 90)
  • Number of Days With Spotting-only in Reference Period 1(From Day 1 to Day 90)
  • Number of Spotting-only Episodes in Reference Period 4(From Day 271 to Day 360)
  • Mean Length of Spotting-only Episodes in Reference Period 2(From Day 91 to Day 180)
  • Maximum Length of Bleeding / Spotting Episodes in Reference Period 1(From Day 1 to Day 90)
  • Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 1(From Day 1 to Day 90)
  • Number of Days With Spotting-only in Reference Period 3(From Day 181 to Day 270)
  • Number of Spotting-only Episodes in Reference Period 2(From Day 91 to Day 180)
  • Mean Length of Spotting-only Episodes in Reference Period 1(From Day 1 to Day 90)
  • Mean Length of Spotting-only Episodes in Reference Period 3(From Day 181 to Day 270)
  • Percentage of Participants With / Without Withdrawal Bleeding at Cycle 3(At Cycle 3 (28 days per Cycle))
  • Percentage of Participants With / Without Withdrawal Bleeding at Cycle 6(At Cycle 6 (28 days per Cycle))
  • Onset of Withdrawal Bleeding Episodes at Cycle 13(At Cycle 13 (28 days per Cycle))
  • Maximum Length of Spotting-only Episodes in Reference Period 1(From Day 1 to Day 90)
  • Maximum Length of Spotting-only Episodes in Reference Period 3(From Day 181 to Day 270)
  • Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 13(At Cycle 13 (28 days per Cycle))
  • Number of Intracyclic Bleeding Episodes at Cycle 13(At Cycle 13 (28 days per Cycle))
  • Number of Intracyclic Bleeding Days at Cycle 1(At Cycle 1 (28 days per Cycle))
  • Percentage of Participants With / Without Withdrawal Bleeding at Cycle 1(At Cycle 1 (28 days per Cycle))
  • Length of Withdrawal Bleeding Episodes at Cycle 3(At Cycle 3 (28 days per Cycle))
  • Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3(At Cycle 3 (28 days per Cycle))
  • Onset of Withdrawal Bleeding Episodes at Cycle 1(At Cycle 1 (28 days per Cycle))
  • Onset of Withdrawal Bleeding Episodes at Cycle 3(At Cycle 3 (28 days per Cycle))
  • Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 1(At Cycle 1 (28 days per Cycle))
  • Number of Intracyclic Bleeding Episodes at Cycle 3(At Cycle 3 (28 days per Cycle))
  • Number of Intracyclic Bleeding Days at Cycle 13(At Cycle 13 (28 days per Cycle))
  • Percentage of Participants With / Without Withdrawal Bleeding at Cycle 13(At Cycle 13 (28 days per Cycle))
  • Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 3(At Cycle 3 (28 days per Cycle))
  • Maximum Length of Intracyclic Bleeding Episodes at Cycle 6(At Cycle 6 (28 days per Cycle))
  • Percentage of Participants With at Least 1 Intracyclic Bleeding Episode at Cycles 2 to 6(Cycles 2 to 6 (28 days per Cycle))
  • Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI)(Baseline up to Cycle 6 (28 days per Cycle))
  • Mean Change From Baseline to Cycle 13 in Psychological General Well-Being Index (PGWBI)(Baseline up to Cycle 13 (28 days per Cycle))
  • Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 6(At Cycle 6 (28 days per Cycle))
  • Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 13(At Cycle 13 (28 days per Cycle))
  • Onset of Withdrawal Bleeding Episodes at Cycle 6(At Cycle 6 (28 days per Cycle))
  • Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 6(At Cycle 6 (28 days per Cycle))
  • Number of Intracyclic Bleeding Episodes at Cycle 1(At Cycle 1 (28 days per Cycle))
  • Number of Intracyclic Bleeding Episodes at Cycle 6(At Cycle 6 (28 days per Cycle))
  • Maximum Length of Intracyclic Bleeding Episodes at Cycle 3(At Cycle 3 (28 days per Cycle))
  • Maximum Length of Intracyclic Bleeding Episodes at Cycle 13(At Cycle 13 (28 days per Cycle))
  • Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Physical Health(Baseline up to Cycle 13 (28 days per Cycle))
  • Maximum Length of Intracyclic Bleeding Episodes at Cycle 1(At Cycle 1 (28 days per Cycle))
  • Number of Intracyclic Bleeding Days at Cycle 3(At Cycle 3 (28 days per Cycle))
  • Number of Intracyclic Bleeding Days at Cycle 6(At Cycle 6 (28 days per Cycle))
  • Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3(At Cycle 3 (28 days per Cycle))
  • Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 6(At Cycle 6 (28 days per Cycle))
  • Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Participant Feeling(Baseline up to Cycle 13 (28 days per Cycle))
  • Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - General Activities(Baseline up to Cycle 13 (28 days per Cycle))
  • Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1(At Cycle 1 (28 days per Cycle))
  • Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 13(At Cycle 13 (28 days per Cycle))
  • Percentage of Participants With at Least 1 Intracyclic Bleeding Episode at Cycles 2 to 13(Cycles 2 to 13 (28 days per Cycle))
  • Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Work(Baseline up to Cycle 6 (28 days per Cycle))
  • Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Household Duties(Baseline up to Cycle 6 (28 days per Cycle))
  • Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Leisure Time Activities(Baseline up to Cycle 6 (28 days per Cycle))
  • Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Social Relationship(Baseline up to Cycle 13 (28 days per Cycle))
  • Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Item Satisfaction(Baseline up to Cycle 13 (28 days per Cycle))
  • Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Physical Health(Baseline up to Cycle 6 (28 days per Cycle))
  • Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Leisure Time Activities(Baseline up to Cycle 13 (28 days per Cycle))
  • Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - General Activities(Baseline up to Cycle 6 (28 days per Cycle))
  • Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Participant Feeling(Baseline up to Cycle 6 (28 days per Cycle))
  • Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Work(Baseline up to Cycle 13 (28 days per Cycle))
  • Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Item Satisfaction(Baseline up to Cycle 6 (28 days per Cycle))
  • Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Overall Life Satisfaction and Contentment(Baseline up to Cycle 6 (28 days per Cycle))
  • Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Overall Life Satisfaction and Contentment(Baseline up to Cycle 13 (28 days per Cycle))
  • Percentage of Participants With Improvement in the Investigator's Assessment in Clinical Global Impression (CGI) at Cycle 6(At Cycle 6 (28 days per Cycle))
  • Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Household Duties(Baseline up to Cycle 13 (28 days per Cycle))
  • Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - School/Course Work(Baseline up to Cycle 6 (28 days per Cycle))
  • Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - School/Course Work(Baseline up to Cycle 13 (28 days per Cycle))
  • Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Social Relationship(Baseline up to Cycle 6 (28 days per Cycle))
  • Percentage of Participants With Improvement in the Participant's Assessment in Clinical Global Impression (CGI) at Cycle 6(At Cycle 6 (28 days per Cycle))
  • Percentage of Participants With Improvement in the Investigator's Assessment in Clinical Global Impression (CGI) at Cycle 13(At Cycle 13 (28 days per Cycle))
  • Percentage of Participants With Improvement in the Participant's Assessment in Clinical Global Impression (CGI) at Cycle 13(At Cycle 13 (28 days per Cycle))

研究者

发起方
Bayer
申办方类型
Industry
责任方
Sponsor

相似试验

已完成
2 期
A Multicenter Study to Evaluate the Effects of a 91-day Oral Contraceptive on Bone Mineral Density in Adolescent FemalesBone Mineral Density
NCT00924560Duramed Research1,361
已完成
1 期
A Study to Evaluate Ovarian Follicular Activity and Hormone Levels for DR-102 Compared to Two 28-Day Oral ContraceptivesFollicle DevelopmentOvarian FollicleFollicle CountFollicle SizeOral Contraceptive
NCT01291004Teva Branded Pharmaceutical Products R&D, Inc.206
已完成
3 期
Effects on Hemostasis, Lipids, Carbohydrate Metabolism, Adrenal & Thyroid Function of the Combined Oral Contraceptive NOMAC-E2 Compared to a COC Containing LNG-EE (292004)(COMPLETED)(P05764)Contraception
NCT00511355Organon and Co121
已完成
2 期
A Multicenter Study to Evaluate the Effects of a 91-Day Extended Cycle Oral Contraceptive on Hemostatic Parameters in Healthy WomenHemostasisOral Contraceptive
NCT01252186Teva Women's Health265
已完成
3 期
Comparative Trial in Hormone Withdrawal Associated SymptomsOral Contraceptive
NCT01076582Bayer592