Primary Ovarian InsufficiencyPhase 4NCT05021094
Clinical Observation on Kuntai Capsule in Treating Early-onset Ovarian Hypofunction
A Phase 4 study testing Kuntai Capsule and Femoston in people with Primary Ovarian Insufficiency, run by Affiliated Hospital of Nantong University at 6 sites in China.
Trial summary
To evaluate the efficacy and safety of Kuntai capsule alone or combined with hormone therapy in improving ovarian function in POI patients (including subclinical stage). Read more about this study
- Who is it for?
- Ages 18 to 39 years, women only
- Conditions the study is for
- Primary Ovarian Insufficiency
- What is being tested?
- Kuntai Capsule and Femoston
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 6 sitesChina
- Study dates
- 22 Oct 2021to 31 Dec 2023
- Phase
- Phase 4
- 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 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- The women aged <40 years old.
- Serum basal follicle stimulating hormone (FSH) level ≥15 IU/L at least twice inspection (two occasions >4 weeks apart). Rare menstruation or menopause for at least 4 months.
- Individuals meeting the above criteria who voluntarily consented to study participation.
Who cannot join
- Pregnant and lactating patients;
- Patients with endometriosis, adenomyosis, endometrial lesions (submucous fibroids, endometrial polyps, etc.), hysteromyoma > 4cm or hysterectomy;
- Patients with known or suspected breast cancer history and estrogen-dependent malignant tumor;
- Patients with personal history of venous thromboembolism (VTE) or high risk of VTE (including body mass index > 30 kg/m2, smoking and family history of thrombosis);
- Patients with porphyria;
- Patients with serious primary diseases or mental illness such as cardiovascular, liver, kidney and hematopoietic system;
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- Patients who are participating in other clinical trials or have participated in other clinical trials in the past three months;
- Patients who suspect or have a history of alcohol and drug abuse;
- Patients who are known to be allergic to the test drugs or their components;
- The researchers determined that patients are not suitable for this trial.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
Hai'an People's Hospital
Hai’an, Jiangsu, 226600
Hong Lu, master, 13862711105
- Recruiting
Hai'an Hospital of traditional Chinese Medicine
Huai'an, Jiangsu, 226600
Ling Chen, master, 18934506298
- Recruiting
Nantong First People's Hospital
Nantong, Jiangsu, 226001
Yanli Zheng, Master, +8613962910099
- Recruiting
Nantong Hospital of Traditional Chinese Medicine
Nantong, Jiangsu, 226001
Dongmei C Chen, Master, 13485105619
- Recruiting
Affiliated Hospital of Nantong University
Nantong, Jiangsu
Yuanquan Zhang, Professor, +8613706299363, jsnt_zhangyuquan@163.com
- Recruiting
Rugao Boai Hospital
Ru'gao, Jiangsu, 226500
Sifang Zhang, bachelor, 18752861616
About this study
Official title: A Multi-center Clinical Study on the Efficacy and Safety of Kuntai Capsule Alone and in Combination With Hormones in the Treatment of Early-onset Hypoovarian Function
To evaluate the efficacy and safety of Kuntai capsule alone or combined with hormone therapy in improving ovarian function in POI patients (including subclinical stage).
Read the detailed description
The study is expected to be conducted between 2021.08 and 2023.12.120 subjects with early-onset ovarian insufficiency will be randomly assigned to trial, control, or combination groups using a computer-generated randomization table.By comparing the data of primary efficacy indexes, secondary efficacy indexes and safety indexes before and after medication, The principal investigator will write and publish the paper.
- Conditions
- Primary Ovarian Insufficiency
- Being tested
- Kuntai Capsule, Femoston
- Medical subject headings
- Primary Ovarian Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kuntai CapsuleDrug
Also called Kuntai Jiaonang
The instructions is pointed that each Kuntai capsule is 0.5g and the usage of Kuntai capsule is oral taking 4 capsules each time, 3 times a day, and 4 weeks is a course of treatment. The patients will taking 3 courses of treatment in this study.
FemostonDrug
Also called Complex Packing Estradiol Tablets/Estradiol and Dydrogesterone Tablets
The estrogen and progesterone sequential regimen was adopted. The Femoston was contain estradiol tablets and estradiol didroxyprogesterone tablets. Red tablets (estradiol, 2 mg/d) were taken in the first 14 days, and gray tablets (estradiol, 2 mg/d, dydrogesterone,10 mg/d) were taken in the last 14 days. 28 days was a course of treatment, and three courses of treatment were taken. The patients will taking 3 courses of treatment in this study.
| Study group | Role | What they receive |
|---|---|---|
| POI patients who taking Kuntai capsule | Experimental | Patients in this group will take Kuntai capsule orally, 4 capsules each time, 3 times a day, and take the medicine for 3 courses. Receives: Drug: Kuntai Capsule |
| POI patients who accepting hormone therapy | Active comparator | The estrogen and progesterone sequential regimen was adopted. The drug was estradiol tablets/estradiol didroxyprogesterone tablets (Femoston). Red tablets (estradiol, 2mg/d) were taken in the first 14 days, and gray tablets (estradiol, 2mg/d, dydrogesterone,10 mg/d) were taken in the last 14 days. 28 days was a course of treatment, and 3 courses of treatment were taken. Receives: Drug: Femoston |
| POI patients who taking Kuntai capsule combined with hormone therapy | Experimental | Kuntai capsule was taken at the same dose as Kuntai group on the basis of hormone therapy for 3 courses. Receives: Drug: Kuntai Capsule; Drug: Femoston |
| Subclinical POI patients who taking Kuntai capsule | Experimental | Subclinical POI patients in this group which with Kuntai capsule intervention. This group is a self-controlled experiment before and after treatment Receives: Drug: Kuntai Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Follicle-stimulating hormone (FSH)
Changes of the level of FSH before and after treatment
Measured: Baseline, 3 months, 6 months
Kupperman Score
Changes of the Kupperman score before and after treatment，Kupperman Score ranges from 0 to 69, with the smaller the score, the better off the subject
Measured: Baseline, 3 months, 6 months
Secondary outcomes (9)
Luteinizing hormone (LH)
Changes of the level of LH before and after treatment
Measured: Baseline, 3 months, 6 months
Estradiol hormone (E2)
Changes of the level of Estradiol hormone before and after treatment
Measured: Baseline, 3 months, 6 months
Antral follicle count (AFC)
Changes of the AFC before and after treatment
Measured: Baseline, 3 months,
anti-Müllerian hormone (AMH)
Changes of the level of AMH before and after treatment
Measured: Baseline, 3 months,
The peak systolic blood flow velocity （PSV）
The peak systolic blood flow velocity before and after treatment was assessed by vaginal B ultrasound
Measured: Baseline, 3 months,
The end-diastolic blood flow velocity（EDV）
The uterine artery end-diastolic blood flow velocity before and after treatment was assessed by vaginal B ultrasound
Measured: Baseline, 3 months,
Uterine artery resistance index（RI）
The uterine artery resistance index before and after treatment was assessed by vaginal B ultrasound
Measured: Baseline, 3 months,
Proportion of patients with normal menstruation
To measure the ratio of patients have normal menstruation after treatment
Measured: Baseline，3 months, 6 months, 9 months
Pregnancy situation
To ask the patient if there is pregnancy (for patient who has pregnancy need)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start22 Oct 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Ovarian InsufficiencyStudies of the same condition, open and under way.
- More trials run by Affiliated Hospital of Nantong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Subclinical POI and POI patients
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Nantong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuquan Zhang, Affiliated Hospital of Nantong University
- Investigators
- Yuquan Zhang, Professor, Principal investigator, Affiliated Hospital of Nantong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05021094
- Sponsor's protocol ID
- AHNantong-POI
- Status last verified
- Sep 2022
- First submitted
- 4 Aug 2021
- Last updated
- 9 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not planning sharing at present.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Clinical Study on the Efficacy and Safety of Kuntai Capsule Alone and in Combination With Hormones in the Treatment of Early-onset Hypoovarian Function
- ClinicalTrials.gov ID
- NCT05021094
- Acronym / sponsor ID
- AHNantong-POI
- Conditions
- Primary Ovarian Insufficiency
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Affiliated Hospital of Nantong UniversityUniversity, hospital or other
- Study start
- 22 Oct 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 25 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy and safety of Kuntai capsule alone or combined with hormone therapy in improving ovarian function in POI patients (including subclinical stage).
Detailed description
The study is expected to be conducted between 2021.08 and 2023.12.120 subjects with early-onset ovarian insufficiency will be randomly assigned to trial, control, or combination groups using a computer-generated randomization table.By comparing the data of primary efficacy indexes, secondary efficacy indexes and safety indexes before and after medication, The principal investigator will write and publish the paper.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Subclinical POI and POI patients
| Arm | Type | Receives |
|---|---|---|
| POI patients who taking Kuntai capsule | Experimental | Drug: Kuntai CapsulePatients in this group will take Kuntai capsule orally, 4 capsules each time, 3 times a day, and take the medicine for 3 courses. |
| POI patients who accepting hormone therapy | Active comparator | Drug: FemostonThe estrogen and progesterone sequential regimen was adopted. The drug was estradiol tablets/estradiol didroxyprogesterone tablets (Femoston). Red tablets (estradiol, 2mg/d) were taken in the first 14 days, and gray tablets (estradiol, 2mg/d, dydrogesterone,10 mg/d) were taken in the last 14 days. 28 days was a course of treatment, and 3 courses of treatment were taken. |
| POI patients who taking Kuntai capsule combined with hormone therapy | Experimental | Drug: Kuntai Capsule, Drug: FemostonKuntai capsule was taken at the same dose as Kuntai group on the basis of hormone therapy for 3 courses. |
| Subclinical POI patients who taking Kuntai capsule | Experimental | Drug: Kuntai CapsuleSubclinical POI patients in this group which with Kuntai capsule intervention. This group is a self-controlled experiment before and after treatment |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- The women aged <40 years old.
- Serum basal follicle stimulating hormone (FSH) level ≥15 IU/L at least twice inspection (two occasions >4 weeks apart). Rare menstruation or menopause for at least 4 months.
- Individuals meeting the above criteria who voluntarily consented to study participation.
Key exclusion criteria (10 listed)
- Pregnant and lactating patients;
- Patients with endometriosis, adenomyosis, endometrial lesions (submucous fibroids, endometrial polyps, etc.), hysteromyoma > 4cm or hysterectomy;
- Patients with known or suspected breast cancer history and estrogen-dependent malignant tumor;
- Patients with personal history of venous thromboembolism (VTE) or high risk of VTE (including body mass index > 30 kg/m2, smoking and family history of thrombosis);
- Patients with porphyria;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kuntai CapsuleAlso: Kuntai JiaonangThe instructions is pointed that each Kuntai capsule is 0.5g and the usage of Kuntai capsule is oral taking 4 capsules each time, 3 times a day, and 4 weeks is a course of treatment. The patients will taking 3 courses of treatment in this study. | Drug | POI patients who taking Kuntai capsule, POI patients who taking Kuntai capsule combined with hormone therapy, Subclinical POI patients who taking Kuntai capsule |
| FemostonAlso: Complex Packing Estradiol Tablets/Estradiol and Dydrogesterone TabletsThe estrogen and progesterone sequential regimen was adopted. The Femoston was contain estradiol tablets and estradiol didroxyprogesterone tablets. Red tablets (estradiol, 2 mg/d) were taken in the first 14 days, and gray tablets (estradiol, 2 mg/d, dydrogesterone,10 mg/d) were taken in the last 14 days. 28 days was a course of treatment, and three courses of treatment were taken. The patients will taking 3 courses of treatment in this study. | Drug | POI patients who accepting hormone therapy, POI patients who taking Kuntai capsule combined with hormone therapy |
Primary outcome
Follicle-stimulating hormone (FSH)
Time frame: Baseline, 3 months, 6 months
Changes of the level of FSH before and after treatment
Kupperman Score
Time frame: Baseline, 3 months, 6 months
Changes of the Kupperman score before and after treatment，Kupperman Score ranges from 0 to 69, with the smaller the score, the better off the subject
9 secondary outcomes
Luteinizing hormone (LH)
Time frame: Baseline, 3 months, 6 months
Estradiol hormone (E2)
Time frame: Baseline, 3 months, 6 months
Antral follicle count (AFC)
Time frame: Baseline, 3 months,
anti-Müllerian hormone (AMH)
Time frame: Baseline, 3 months,
The peak systolic blood flow velocity （PSV）
Time frame: Baseline, 3 months,
The end-diastolic blood flow velocity（EDV）
Time frame: Baseline, 3 months,
Uterine artery resistance index（RI）
Time frame: Baseline, 3 months,
Proportion of patients with normal menstruation
Time frame: Baseline，3 months, 6 months, 9 months
Pregnancy situation
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2022.
- Individual participant dataSharing planned: No. Not planning sharing at present.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuquan Zhang, Professor principal investigator
Affiliated Hospital of Nantong University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Kuntai Capsule and Femoston in people with Primary Ovarian Insufficiency, run by Affiliated Hospital of Nantong University at 6 sites 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 3 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 9 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuquan Zhang, Professor (+8613706299363, jsnt_zhangyuquan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Follicle-stimulating hormone (FSH) (time frame: Baseline, 3 months, 6 months). 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?
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 9 Sep 2022.