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The Pharmacokinetic(PK)/Pharmacodynamics(PD) Study of SHR7280 Tablets in Premenopausal Subjects With Endometriosis.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04417972
Recruitment Status : Not yet recruiting
First Posted : June 5, 2020
Last Update Posted : June 5, 2020
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

Brief Summary:
The primary objective of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR7280 tablets in premenopausal subjects with endometriosis. In addition, this study will provide information on efficacy of SHR7280 tablets in premenopausal subjects with endometriosis.

Condition or disease Intervention/treatment Phase
Endometriosis Drug: SHR7280 Drug: Placebo oral tablet Phase 1 Phase 2

Detailed Description:
Endometriosis is a common disease, affecting 5-10% of women of reproductive age . It is an estrogen-dependent and estrogen-driven disease and so hormonal manipulation and suppression of estrogen production form the basis of the majority of medical treatment. The primary objective of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR7280 tablets in premenopausal subjects with endometriosis. In addition, this study will provide information on efficacy of SHR7280 tablets in premenopausal subjects with endometriosis.

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Study Type : Interventional
Estimated Enrollment : 166 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase I/II, Randomized, Double-Blind, Placebo-Controlled, Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics ,Pharmacodynamics and Efficacy of SHR7280 Tablets in Premenopausal Subjects With Endometriosis.
Estimated Study Start Date : May 25, 2020
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : May 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

Arm Intervention/treatment
Experimental: SHR7280 dose 1
oral administration for 21days,Phase I
Drug: SHR7280
treatment

Drug: Placebo oral tablet
blank control

Experimental: SHR7280 dose 2
oral administration for 21days,Phase I
Drug: SHR7280
treatment

Drug: Placebo oral tablet
blank control

Experimental: SHR7280 dose 3
oral administration for 21days,Phase I
Drug: SHR7280
treatment

Drug: Placebo oral tablet
blank control

Experimental: SHR7280 dose 4
oral administration for 21days,Phase I
Drug: SHR7280
treatment

Drug: Placebo oral tablet
blank control

Active Comparator: SHR7280 low dose
oral administration for 84days,Phase II
Drug: SHR7280
treatment

Active Comparator: SHR7280 high dose
oral administration for 84days, Phase II
Drug: SHR7280
treatment

Placebo Comparator: Placebo
oral administration for 84days, Phase II
Drug: Placebo oral tablet
blank control




Primary Outcome Measures :
  1. Number of Participants with Adverse events [ Time Frame: Pre-dose to 28±2 days after dose administration ]
    Phase I

  2. Change From Baseline in the Monthly Mean Dysmenorrhea Score at weeks 12 [ Time Frame: Baseline and weeks 12 ]
    Phase II daily assessment of dysmenorrhea score on a 4-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe) using an e-Diary.


Secondary Outcome Measures :
  1. Area under the plasma concentration versus time curve (AUC) of SHR7280 [ Time Frame: dAt pre-defined intervals from initial dose through final study visit (28±2 days after dose administration) ]
    Phase I

  2. Time to maximum plasma concentration(Tmax) of SHR7280 [ Time Frame: At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration) ]
    Phase I

  3. Maximum plasma concentration(Cmax) of SHR7280 [ Time Frame: At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration) ]
    Phase I

  4. Half-time(t1/2) of SHR7280 [ Time Frame: At pre-defined intervals from initial dose through final study visit(28±2 days after dose administration) ]
    Phase I

  5. Apparent clearance(CL/F) of SHR7280 [ Time Frame: At pre-defined intervals from initial dose through final study visit(28±2 days after dose administration) ]
    Phase I

  6. Apparent volume of distribution(Vz/F) of SHR7280 [ Time Frame: At pre-defined intervals from initial dose through final study visit(28±2 days after dose administration) ]
    Phase I

  7. Concentration of Estradiol(E2) [ Time Frame: At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration) ]
    Phase I

  8. Concentration of Progesterone(P) [ Time Frame: At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration) ]
    Phase I

  9. Concentration of Follicle stimulating hormone(FSH) [ Time Frame: At pre-defined intervals from initial dose through final study visit(28±2 days after dose administration) ]
    Phase I

  10. Concentration of Luteinizing hormone(LH) [ Time Frame: At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration) ]
    Phase I

  11. Change From Baseline in the Monthly Mean Dysmenorrhea Score [ Time Frame: Baseline and weeks 8、12 ]
    Phase II daily assessment of dysmenorrhea score on a 4-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe) using an e-Diary.

  12. Change From Baseline in the Monthly Mean Non-menstrual Pelvic Pain Score [ Time Frame: Baseline and weeks 4、8、12 ]
    Phase II daily assessment of non-menstrual pelvic pain on a 4-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe) using an e-Diary.

  13. Change From Baseline in the Monthly Mean Dyspareunia Score [ Time Frame: Baseline and weeks 4、8、12 ]
    Phase II daily assessment of dyspareunia on a 4-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe) using an e-Diary.

  14. Number of Participants with Adverse events [ Time Frame: during Pre and 28±3 days after dose administration ]
    Phase II

  15. Cmax, ss of SHR7280 [ Time Frame: At pre-defined intervals from initial dose through final study visit (28±3 days after dose administration) ]
    Phase II

  16. Cmin, ss of SHR7280 [ Time Frame: At pre-defined intervals from initial dose through final study visit (28±3 days after dose administration) ]
    Phase II

  17. AUCt, ss of SHR7280 [ Time Frame: At pre-defined intervals from initial dose through final study visit (28±3 days after dose administration) ]
    Phase II

  18. Concentration of Estradiol(E2) [ Time Frame: At pre-defined intervals from initial dose through final study visit(28±3 days after dose administration) ]
    Phase II

  19. Concentration of Progesterone(P) [ Time Frame: At pre-defined intervals from initial dose through final study visit (28±3 days after dose administration) ]
    Phase II

  20. Concentration of Luteinizing hormone(LH) [ Time Frame: At pre-defined intervals from initial dose through final study visit (28±3 days after dose administration) ]
    Phase II

  21. Concentration of Follicle stimulating hormone(FSH) [ Time Frame: At pre-defined intervals from initial dose through final study visit(28±3 days after dose administration) ]
    Phase II



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Phase I/II

  1. premenopausal females, aged 18-45
  2. History of regular menstrual cycles
  3. Participant has a documented surgical diagnosis (e.g., laparoscopy or laparotomy) of endometriosis established by visualization within 10 years prior to entry into Washout or Screening.
  4. Participant must agree to use only protocol specified rescue analgesics during the Screening and Treatment Periods for endometriosis-associated pain
  5. Participant in general good health. No clinically significant findings in laboratory parameters or clinically significant abnormality on X-ray

Phase I (only) Participant has mild or moderate pelvic pain associated with endometriosis, VAS≤60mm at Screening

Phase II(only)

  1. Participant has moderate or severe pelvic pain associated with endometriosis,VAS>30mm at Screening and Baseline
  2. Participant must have the following documented in the e-Diary: at least 2 days of "moderate" or "severe" Dysmenorrhea (DYS≥2) during baseline and DYS≥2 on D-1 prior to randomization

Exclusion Criteria:

Phase I/II

  1. Subjects with severe trauma or surgery within 6 months prior to the screening;
  2. Known blood donation within 30 days pre-dose; donating≥200 ml of blood 2 months pre-dose;
  3. Pregnant or Serum β-human chorionic gonadotropin (hCG)> 5 MillionInternationalUnits(mIU)/mL at screening or baseline
  4. Pregnant or breast feeding ;
  5. Planning a pregnancy within the next 12 months
  6. Have pelvic pain that is not caused by endometriosis
  7. Abnormal uterine bleeding
  8. Are currently receiving gonadotropin-releasing hormone (GnRH) agonist, a GnRH antagonist or danazol or have received any of these agents within 6 months of the start of screening.
  9. Are currently receiving subcutaneous medroxyprogesterone acetate (DMPA-SC) or intramuscular medroxyprogesterone acetate (DMPA-IM) or have received any of these agents within 3 months of the start of screening.
  10. Are currently using hormonal contraception or other forms of hormonal therapy or received such treatment within the last month.

Phase I (only) one month prior to screening involved in any drug or medical device clinical subjects, or within 5 half-life of drugs before screening;

Phase II (only) Participant have bone mineral density(BMD) with either lumbar spine (L2-L4)T-scores below -2.5 at screening as determined by the central dual energy x-ray absorptiometry( DXA) facility,diagnosed osteoporosis


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04417972


Contacts
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Contact: Lihong Zhuang, M.D +86 18001991273 zhuanglihong@hrglobe.cn
Contact: Hongyue Yan, M.D +86 18915605217 yanhongyue@hrglobe.cn

Locations
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China, Beijing
Peking University Third Hospital
Peking, Beijing, China
Contact: Hongyan Guo, PhD    +86 18610257069    bysyghy@163.com   
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
Investigators
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Principal Investigator: Hongyan Guo, PhD Peking University Third Hospital
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Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT04417972    
Other Study ID Numbers: SHR7280-102
First Posted: June 5, 2020    Key Record Dates
Last Update Posted: June 5, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Endometriosis