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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Peking Union Medical College Hospital
  Beijing, China Recruiting

Study contacts

• Study coordinator: Yan Deng, Doctor
• Email: yanndeng@163.com
• Phone: 86+010-69158331

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.