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NCT04417972CompletedPhase 1/2

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

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.

Source: ClinicalTrials.gov · Last updated 8 Jul 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
179 (actual)
First submitted
21 May 2020
Start date
30 Jul 2020
Primary completion date
14 May 2024
Lead sponsor
Jiangsu HengRui Medicine Co., Ltd.
NCT number
NCT04417972

What you commit to

  • Study type: Interventional · Phase 1/2
  • Participants enrolled: 179
  • From 30 Jul 2020 to the primary completion date, 14 May 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Subjects with severe trauma or surgery within 6 months prior to the screening;
  • 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.
  • 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.
  • Are currently using hormonal contraception or other forms of hormonal therapy or received such treatment within 2 months of the start of screening.
    • 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) Screening dual-energy x-ray absorptiometry (DXA) scan results of the lumbar spine, femoral neck, or total hip bone mineral density corresponding to 1.5 or more standard deviations below normal (T-score at or below -1.5)

Other illness

  • Abnormal uterine bleeding

Lab values

  • Pregnant or Serum β-human chorionic gonadotropin (hCG)\> 5 Million International Units(mIU)/mL at screening or baseline

Other

  • Phase I/II
  • Known blood donation within 30 days pre-dose; donating≥200 ml of blood 2 months pre-dose;
  • Pregnant or breast feeding ;
  • Have pelvic pain that is not caused by endometriosis

Who the study is looking for

  • Phase I/II
  • premenopausal females, aged 18-45
  • History of regular menstrual cycles
  • Endometriosis participant diagnosed by surgical (e.g., laparoscopy or laparotomy) or by magnetic resonance imaging or ultrasonography.
  • Participant must agree to use only protocol specified rescue analgesics during the Screening and Treatment Periods for endometriosis-associated pain.
  • 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 at Screening.
    • Phase II(only) Participant has moderate or severe pelvic pain associated with endometriosis at Screening.

Age in the registry: 18 years to 45 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Peking University Third Hospital
Coordinator of this site? Confirm its status
BeijingChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.