UnknownPhase 4

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

China120 participantsStarted 2021-10-22

Plain-language 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).

Who can participate

Age range18 Years – 39 Years

SexFEMALE

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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;
✕. 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;

What they're measuring

Follicle-stimulating hormone (FSH)

Timeframe: Baseline, 3 months, 6 months

Kupperman Score

Timeframe: Baseline, 3 months, 6 months

Trial details

NCT IDNCT05021094

SponsorAffiliated Hospital of Nantong University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-31

Contact for this trial

Yuquan Zhang, Professor

+8613706299363 jsnt_zhangyuquan@163.com

View on ClinicalTrials.gov More Primary Ovarian Insufficiency trials