Combining Chinese and Western medicine to restore menstrual cycles in hypothalamic amenorrhea

The Research of Integrated Traditional Chinese and Western Medicine on Hypothalamic Amenorrhea

This program will try a two-step approach—Western medicine to quickly restore menstrual bleeding and traditional Chinese medicine to support long-term hormonal balance—for women with functional hypothalamic amenorrhea.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 210 (estimated)
• Ages: 14 Years to 40 Years
• Sex: Female
• Sponsor: Peking Union Medical College Hospital (Academic / other)
• Locations: 1 site (Beijing)
• Trial ID: NCT07580950 on ClinicalTrials.gov

What this trial studies

This is a randomized, multi-center Phase 4 trial enrolling 210 patients to test a two-step cycle-regulating approach that pairs Western medicines for rapid resumption of menses with traditional Chinese medicine formulations aimed at nourishing kidney function and soothing liver qi. Participants will be randomized to receive the integrated regimen and followed for safety, menstrual restoration, and biological changes. The study will also analyze gut microbiota and metabolomics to explore mechanisms underlying any treatment effects. Careful eligibility screening excludes organic pituitary/ovarian causes, recent use of relevant drugs, pregnancy or lactation, and severe medical or psychiatric conditions.

Who should consider this trial

Good fit: Women with diagnosed functional hypothalamic amenorrhea (primary or secondary) characterized by low or normal FSH, LH <5 IU/L, estradiol <50 pg/mL, and exclusion of organic pituitary, ovarian, uterine, drug-induced, or other causes are ideal candidates.

Not a fit: Women who recently used relevant medications, are pregnant or breastfeeding, have severe or unstable physical or psychiatric illness, recent substance dependence or heavy smoking, or known allergies to the treatments are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, this combined approach could restore regular menstruation sooner and improve longer-term hormonal balance and symptoms for affected women.

How similar studies have performed: Smaller single-center and observational reports have suggested potential benefits of combining TCM and Western approaches, but high-quality randomized evidence has been limited until now.

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).

Where this trial is running

Beijing

• Peking Union Medical College Hospital — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Yan Deng, Doctor

Conditions Functional Hypothalamic Amenorrhea; Integrated Traditional Chinese and Western Clinical Medicine; Randomized controlled trial