NCT07580950 The Research of Integrated Traditional Chinese and Western Medicine on Hypothalamic Amenorrhea
| NCT ID | NCT07580950 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Peking Union Medical College Hospital |
| Condition | Functional Hypothalamic Amenorrhea |
| Study Type | INTERVENTIONAL |
| Enrollment | 210 participants |
| Start Date | 2025-10-22 |
| Primary Completion | 2028-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 210 participants in total. It began in 2025-10-22 with a primary completion date of 2028-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study aims to validate the efficacy and safety of the "two-step cycle-regulating approach integrating Chinese and Western medicine: rapid restoration of menstruation with Western medicine, and nourish the kidney and soothe the liver, nourishing the essence, and reinforcing the vital essence and strengthening the primordial qi with Chinese medicine" through a nationwide randomized controlled clinical trial involving 210 cases. Guided by traditional Chinese medicine theory, the study will explore the mechanism of integrated Chinese and Western medicine in the treatment of functional hypothalamic amenorrhea through gut microbiota and metabolomics research.
Eligibility Criteria
Inclusion Criteria: Diagnostic criteria for functional hypothalamic amenorrhea 1. primary or secondary amenorrhea 2. Normal or low FSH levels, LH \< 5 IU/L, E2 \< 50 pg/mL 3. Exclusion of amenorrhea caused by: -Organic lesions of the hypothalamus or pituitary gland , Ovarian amenorrhea , Uterine or lower genital tract developmental abnormalities ,Drug-induced amenorrhea ,Other causes of amenorrhea Exclusion Criteria: 1. Individuals who have used relevant medications within the past 3 months 2. History of substance abuse or dependence (alcohol or drugs) within the past 3 months; heavy smokers (those consuming 20 or more cigarettes daily) 3. Individuals with severe or unstable physical illnesses, including liver, kidney, gastrointestinal, cardiovascular, cerebrovascular, respiratory, endocrine, neurological, immune, or hematological disorders; psychiatric patients 4. Lactating or pregnant women, or females within one year postpartum 5. History of allergy to the investigational drug; contraindications to Dingkundan, Bazhen Yimu Pills, or Femoston 6. Individuals with or suspected of having estrogen-sensitive tumors (e.g., endometrial cancer, breast cancer). 7. History of thromboembolic disease or thrombotic tendency. 8. Participation in another investigational drug clinical trial within 1 month prior to inclusion in this study (first interview).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07580950 clinical trial?
This trial is open to female participants only, aged 14 Years or older, up to 40 Years, studying Functional Hypothalamic Amenorrhea. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07580950 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07580950 currently recruiting?
Yes, NCT07580950 is actively recruiting participants. Contact the research team at yanndeng@163.com for enrollment information.
Where is the NCT07580950 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07580950 clinical trial?
NCT07580950 is sponsored by Peking Union Medical College Hospital. The trial plans to enroll 210 participants.