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New fertility drug QL1012D put to the test against Gonal-F®

NCT ID NCT06864793

Knowledge-focused Sponsor: Qilu Pharmaceutical Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 new injectable fertility drug (QL1012D) against an approved one (Gonal-F®) in 48 healthy women aged 18-45. The goal is to see if the new drug works the same way in the body and is just as safe. Participants receive both drugs at different times to compare them directly.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 48 people

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

Started

Apr 2025

Expected to finish

Apr 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 to 45 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Female, Age between 18 to 45 years (inclusive). * Body mass index (BMI) of ≥18 and ≤28 kg/m2, body weight ≥45 kg. * With a history of sexual activity * Regular menstruation cycle (25 to 35 days, inclusive). * Normal sex hormone levels, or abnormalities deemed clinically insignificant by the investigator. * Reached the standard within the time window after receiving the down-regulated drug. * Agreed to take effective contraceptive measures during and 6 months after the end of the study period. * Willing to participate in this clinical trial, understanding the study procedures, and able to provide written informed consent. Exclusion Criteria: * History of ovarian hyperstimulation syndrome, or polycystic ovary syndrome, or ovarian enlargement or cysts not caused by polycystic ovary syndrome, or primary ovarian failure; history of hypothalamic or pituitary tumors; history of malignancy; History of thrombosis; or other diseases that considered to influence the study by the investigator. * Unexplained reproductive tract bleeding. * Thin-layer cytology examination deemed clinically significant by the investigator. * Vital signs, physical examination, 12-lead electrocardiogram, or laboratory examination deemed clinically significant by the investigator with. * Pregnancy or lactation period, or positive human chorionic gonadotropin (HCG) examination. * Known to be allergic to follicle-stimulating hormone (FSH), or gonadotropin-releasing hormone agonists (GnRH-a) or their analogs * Consume strong coffee or tea daily * Historic abuse of alcoholic beverages * Smoke ≥5 cigarettes per day within 3 months prior to the study * History of drug abuse * Unsuitable for participation by the investigator.

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Conditions

The condition(s) this trial relates to.

female infertility

As listed by the trial registrant

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

Infertility, female

Contacts and locations

Locations

  • The First Hospital of Jilin University

    Changchun, Jilin, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.