A Phase 4 interventional study of Kuntai Capsule and Femoston in Primary Ovarian Insufficiency, sponsored by Affiliated Hospital of Nantong University. Status unknown at 6 sites in China. Open to female participants aged 18 Years to 39 Years. Per ClinicalTrials.gov, last updated 2022-09-09.
Sponsored by Affiliated Hospital of Nantong University · Phase 4, Interventional, and Treatment
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).
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.
172 studies on the registry are indexed under Primary Ovarian Insufficiency; 45 are open to participants now.
This study's planned enrollment of 120 is above the median of 49 across 109 interventional studies indexed under Primary Ovarian Insufficiency.
Browse Primary Ovarian Insufficiency studies →Affiliated Hospital of Nantong University is the lead sponsor of 92 studies on the registry; 53 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients in this group will take Kuntai capsule orally, 4 capsules each time, 3 times a day, and take the medicine for 3 courses.
Drug: Kuntai Capsule
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.
Drug: Femoston
Kuntai capsule was taken at the same dose as Kuntai group on the basis of hormone therapy for 3 courses.
Drug: Kuntai Capsule · Drug: Femoston
Subclinical POI patients in this group which with Kuntai capsule intervention. This group is a self-controlled experiment before and after treatment
Drug: Kuntai Capsule
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.
Also known as: Kuntai Jiaonang
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.
Also known as: Complex Packing Estradiol Tablets/Estradiol and Dydrogesterone Tablets
Follicle-stimulating hormone (FSH)
Changes of the level of FSH before and after treatment
Time frame: 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
Time frame: Baseline, 3 months, 6 months
Luteinizing hormone (LH)
Changes of the level of LH before and after treatment
Time frame: Baseline, 3 months, 6 months
Estradiol hormone (E2)
Changes of the level of Estradiol hormone before and after treatment
Time frame: Baseline, 3 months, 6 months
Antral follicle count (AFC)
Changes of the AFC before and after treatment
Time frame: Baseline, 3 months,
anti-Müllerian hormone (AMH)
Changes of the level of AMH before and after treatment
Time frame: 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
Time frame: 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
Time frame: Baseline, 3 months,
Uterine artery resistance index（RI）
The uterine artery resistance index before and after treatment was assessed by vaginal B ultrasound
Time frame: Baseline, 3 months,
Proportion of patients with normal menstruation
To measure the ratio of patients have normal menstruation after treatment
Time frame: Baseline，3 months, 6 months, 9 months
Pregnancy situation
To ask the patient if there is pregnancy (for patient who has pregnancy need)
Time frame: 6 months
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — Not planning sharing at present.
This study is status unknown, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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Primary Ovarian Insufficiency→
Affiliated Hospital of Nantong University