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New study combines eastern and western medicine to restore periods in women

NCT ID NCT07580950

Disease control Sponsor: Peking Union Medical College Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a two-step treatment for functional hypothalamic amenorrhea, a condition where women stop having periods due to stress, low weight, or excessive exercise. It combines Western medicine to quickly restart menstruation with Chinese herbs to support long-term balance. The trial will involve 210 women across China and track hormone levels, menstrual patterns, and quality of life.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 210 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

14 to 40 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

functional hypothalamic amenorrhea

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Functional hypothalamic amenorrhea

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Peking Union Medical College Hospital

    RECRUITING

    Beijing, 100730, China

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