AzTrials
AzTrials

EndometriosisPhase 1/2NCT04417972

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

A Phase 1/2 study testing SHR7280 in people with Endometriosis, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Endometriosis
What is being tested?
SHR7280
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
179 participants
Where
1 siteChina
Study dates
30 Jul 2020to 14 May 2024
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • Phase I/II
  • Subjects with severe trauma or surgery within 6 months prior to the screening；
  • Known blood donation within 30 days pre-dose; donating≥200 ml of blood 2 months pre-dose;
  • Pregnant or Serum β-human chorionic gonadotropin (hCG)> 5 Million International Units(mIU)/mL at screening or baseline
  • Pregnant or breast feeding ;
  • Have pelvic pain that is not caused by endometriosis
Show all 11Show fewer
  • Abnormal uterine bleeding
  • 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)

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peking University Third Hospital

    Beijing, Beijing Municipality

Other trials in China

About this study

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.

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.

Read the 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.

Conditions
Endometriosis
Being tested
SHR7280, Placebo oral tablet
Medical subject headings
Endometriosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SHR7280Drug

    treatment

  • Placebo oral tabletDrug

    blank control

Study groups in NCT04417972
Study groupRoleWhat they receive
SHR7280 dose 1Experimentaloral administration for 21days,Phase I
Receives: Drug: SHR7280; Drug: Placebo oral tablet
SHR7280 dose 2Experimentaloral administration for 21days,Phase I
Receives: Drug: SHR7280; Drug: Placebo oral tablet
SHR7280 dose 3Experimentaloral administration for 21days,Phase I
Receives: Drug: SHR7280; Drug: Placebo oral tablet
SHR7280 dose 4Experimentaloral administration for 21days,Phase I
Receives: Drug: SHR7280; Drug: Placebo oral tablet
SHR7280 low doseActive comparatororal administration for 84days,Phase II
Receives: Drug: SHR7280
SHR7280 high doseActive comparatororal administration for 84days, Phase II
Receives: Drug: SHR7280
PlaceboPlacebo comparatororal administration for 84days, Phase II
Receives: Drug: Placebo oral tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants with Adverse events

    Phase I

    Measured: Pre-dose to 28±2 days after dose administration

  2. Change From Baseline in the 7-day mean score for pelvic pain as measured by VAS at 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.

    Measured: Baseline and weeks 12

Secondary outcomes (17)

  1. PK markers of SHR7280: area under the plasma concentration versus time curve (AUC)

    Phase I \& II

    Measured: At pre-defined intervals from initial dose through final study visit

  2. PK markers of SHR7280: time to maximum plasma concentration(Tmax)

    Phase I \& II

    Measured: At pre-defined intervals from initial dose through final study visit

  3. PK markers of SHR7280: maximum plasma concentration(Cmax)

    Phase I \& II

    Measured: At pre-defined intervals from initial dose through final study visit

  4. PK markers of SHR7280: half-time(t1/2)

    Phase I \& II

    Measured: At pre-defined intervals from initial dose through final study visit

  5. PK markers of SHR7280: apparent clearance(CL/F)

    Phase I \& II

    Measured: At pre-defined intervals from initial dose through final study visit

  6. PK markers of SHR7280: apparent volume of distribution(Vz/F)

    Phase I \& II

    Measured: At pre-defined intervals from initial dose through final study visit

  7. PD markers of SHR7280: Concentration of Estradiol(E2)

    Phase I \& II

    Measured: At pre-defined intervals from initial dose through final study visit

  8. PD markers of SHR7280: Concentration of Progesterone(P)

    Phase I \& II

    Measured: At pre-defined intervals from initial dose through final study visit

  9. PD markers of SHR7280: Concentration of Follicle stimulating hormone(FSH)

    Phase I \& II

    Measured: At pre-defined intervals from initial dose through final study visit

  10. PD markers of SHR7280: Concentration of Luteinizing hormone(LH)

    Phase I \& II

    Measured: At pre-defined intervals from initial dose through final study visit

  11. Change From Baseline in the 7-day mean score for pelvic pain as measured by VAS

    Phase II

    Measured: Baseline and weeks 4、8

  12. Change From Baseline in the Monthly Mean score for pelvic pain as measured by VAS

    Phase II

    Measured: Baseline and weeks 4、8、12

  13. Change From Baseline in the Monthly Mean Dysmenorrhea Score

    Phase II

    Measured: Baseline and weeks 8、12

  14. Change From Baseline in the Monthly Mean Non-menstrual Pelvic Pain Score and Dyspareunia Score

    Phase II

    Measured: Baseline and weeks 4、8、12

  15. Change from baseline to monthly analgesic use to treat endometriosis-associated pain

    Phase II

    Measured: Baseline and weeks 4、8、12

  16. Patient Global Impression of Change (PGIC) score at week 12

    Phase II

    Measured: Week 12

  17. Adverse events

    Measured: during Pre and 28±3 days after dose administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2020
  2. Study start30 Jul 2020
  3. Primary completion14 May 2024
  4. Study completion14 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
179 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04417972
Sponsor's protocol ID
SHR7280-102
Status last verified
Jul 2024
First submitted
21 May 2020
Last updated
8 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Li Y, Zheng Y, Xu B, Cai L, Feng S, Liu Y, Zhu Z, Yu Q, Guo H. Safety, Pharmacokinetics, and Pharmacodynamics of SHR7280, a Non-peptide GnRH Antagonist in Premenopausal Women with Endometriosis: A Randomized, Double-Blind, Placebo-Controlled Phase 1 Study. Clin Pharmacokinet. 2023 Dec;62(12):1739-1748. doi: 10.1007/s40262-023-01315-6. Epub 2023 Oct 14.

    PubMed 37838623

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing SHR7280 in people with Endometriosis, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Adverse events (time frame: Pre-dose to 28±2 days after dose administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04417972, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in