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New hormonal IUD shows promise in early birth control trial

NCT ID NCT00967746

Disease control Sponsor: Organon and Co 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 phase 2 trial tested three different doses of a new hormonal intrauterine system (IUS) releasing etonogestrel against a standard copper IUD for contraception. 84 healthy women who had given birth took part to see how safe and acceptable the devices were, and how they affected vaginal bleeding. The goal was to find the best dose for future studies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
etonogestrel-releasing intrauterine system (hormonal IUD)
What this could lead to
If successful, this could lead to a new hormonal IUD option for birth control with fewer side effects or better bleeding patterns.
What could go wrong
This is an early phase 2 trial with only 84 participants, so results may not apply to everyone. Different doses may cause unexpected bleeding or side effects.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

84 people

The number who actually took part.

Start date

Nov 2009

Finished

Jul 2011

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 40 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: * Healthy female subjects in need for contraception will be selected to participate in the trial; * Each subject must be \>=18 to \<=40 years of age at screening and in need for contraception; * Each subject must have given birth to at least one child (gestational age \>=28 weeks); * Each subject must have a uterus with a measured length between 6.0 and 9.0 cm (extremes included) from external os to fundus uteri. Exclusion Criteria: * A subject must not be pregnant or suspected to be pregnant; * A subject must not have had an ectopic pregnancy in the past or must not have a history or presence of predisposing factors for this condition such as salpingitis, endometritis or pelvic peritonitis; * A subject must not have a history or presence of any malignancy; * A subject must not have a history or presence of premalignant disease of the uterus or cervix, including endometrial hyperplasia, or (other) sex-steroid sensitive premalignancies; * A subject must not have an active venous thromboembolic disorder (e.g. deep vein thrombosis, pulmonary embolism); * A subject must not have a history or presence of severe hepatic disease with AST and/or ALT levels of \>=3 times the upper normal limit; * A subject must not have congenital or acquired malformations or distortions of the uterus or cervix; * A subject must not have large or multiple uterine fibromyomata, or a smaller uterine fibromyoma which may interfere with the insertion of the MIUS/IUD according to the investigator; * A subject must not have vaginal bleeding of undiagnosed etiology; * A subject must not have dysmenorrhea interfering with daily activities or menorrhagia

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As listed by the trial registrant

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

Contraception

Contacts and locations

Locations

  • Dinox GmbH

    Berlin, D-10115, Germany

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