Clinical Observation on Kuntai Capsule in Treating Early-onset Ovarian Hypofunction

Affiliated Hospital of Nantong University

Status and phase: Enrolling; Phase 4

Conditions: Primary Ovarian Insufficiency

Treatments: Drug: Femoston; Drug: Kuntai Capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT05021094

AHNantong-POI

Details and patient eligibility

About

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).

Full 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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18 to 39 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. The women aged <40 years old.
2. 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.
3. Individuals meeting the above criteria who voluntarily consented to study participation.

Exclusion criteria

1. Pregnant and lactating patients;
2. Patients with endometriosis, adenomyosis, endometrial lesions (submucous fibroids, endometrial polyps, etc.), hysteromyoma > 4cm or hysterectomy;
3. Patients with known or suspected breast cancer history and estrogen-dependent malignant tumor;
4. 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);
5. Patients with porphyria;
6. Patients with serious primary diseases or mental illness such as cardiovascular, liver, kidney and hematopoietic system;
7. Patients who are participating in other clinical trials or have participated in other clinical trials in the past three months;
8. Patients who suspect or have a history of alcohol and drug abuse;
9. Patients who are known to be allergic to the test drugs or their components;
10. The researchers determined that patients are not suitable for this trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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120 participants in 4 patient groups

POI patients who taking Kuntai capsule

Experimental group

Description:

Patients in this group will take Kuntai capsule orally, 4 capsules each time, 3 times a day, and take the medicine for 3 courses.

Treatment:

Drug: Kuntai Capsule

POI patients who accepting hormone therapy

Active Comparator group

Description:

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.

Treatment:

Drug: Femoston

POI patients who taking Kuntai capsule combined with hormone therapy

Experimental group

Description:

Kuntai capsule was taken at the same dose as Kuntai group on the basis of hormone therapy for 3 courses.

Treatment:

Drug: Kuntai Capsule

Drug: Femoston

Subclinical POI patients who taking Kuntai capsule

Experimental group

Description:

Subclinical POI patients in this group which with Kuntai capsule intervention. This group is a self-controlled experiment before and after treatment

Treatment:

Drug: Kuntai Capsule