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Uterine FibroidsPhase 2NCT01452659

Efficacy and Safety of TAK-385 in the Treatment of Uterine Fibroids

A Phase 2 study testing TAK-385 in people with Uterine Fibroids, run by Takeda at 27 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine the efficacy and safety of TAK-385, once daily (QD), for 12 weeks in women with uterine fibroids. Read more about this study

Who is it for?
Ages 20 years and older, women only
Conditions the study is for
Uterine Fibroids
What is being tested?
TAK-385
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
216 participants
Where
27 sitesJapan
Study dates
Oct 2011to Sep 2012
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The participant has been diagnosed with uterine fibroids and has never received surgical treatment for the myoma.
  • The participant is a premenopausal woman.
  • The participant has one or more measurable noncalcified myomas confirmed by transvaginal sonography.
  • The participant has experienced regular menstrual cycles
  • The participant is diagnosed as menorrhagia

Who cannot join

  • Participants with a screening Hb <8 g/dL
  • Participants with a previous or current history of blood disorders
  • Participants with a known history of severe hypersensitivity or severe allergy to sanitary goods
  • Participants with lower abdominal pain due to irritable bowel syndrome or severe interstitial cystitis
  • Participants with a previous or current history of thyroid dysfunction
  • Participants with a previous or current history of pelvic inflammatory disease
Show all 19Show fewer
  • Participants with a positive PAP smear test result
  • Participants with a history of panhysterectomy or bilateral oophorectomy
  • Participants judged by investigator to have marked abnormal uterine bleeding or anovulatory bleeding
  • Participants with a previous or current history of a malignant tumor
  • Participants who have been treated with any of the following drugs: anticoagulant drug, antiplatelet drug, tranexamic acid, selective estrogen receptor modulator (SERM), activated vitamin D, other vitamin D, calcitonin, ipriflavone, steroid hormone, vitamin K, teriparatide, or denosumab
  • Participants who have been treated with any of the following drugs: oral contraceptive and sex hormone preparation, gonadotropin-releasing hormone (GnRH) analogue, dienogest, danazol, or aromatase inhibitor
  • Participants who have been treated with a bisphosphonate preparation
  • Participants with a previous or current history of severe hypersensitivity or severe allergy to drugs
  • Participants with non-diagnosable abnormal genital bleeding
  • Participants with a previous or current history of osteoporosis, bone mass loss, or other metabolic bone diseases
  • Participants with clinically significant cardiovascular disease or uncontrollable hypertension
  • Participants judged by investigator to be inappropriate to participate in this study based on the 12-lead electrocardiogram (ECG) findings
  • Participants with active liver disease or jaundice, or with alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin > 1.5 times the upper limit of normal (ULN)

Trial locations and contacts

27 sites in 1 country.

27 sites in 1 country

Japan27 sites

  • Study site

    Amagasaki-shi, Hyōgo

  • Study site

    Chiba, Chiba

  • Study site

    Chuo-ku, Tokyo

  • Study site

    Ebetsu-shi, Hokkaido

  • Study site

    Fukui-shi, Fukui

  • Study site

    Fukuoka, Fukuoka

  • Study site

    Ibaraki-shi, Osaka

  • Study site

    Iizuka-shi, Fukuoka

  • Study site

    Itchihara-shi, Chiba

  • Study site

    Kamakura-shi, Kanagawa

  • Study site

    Kobe, Hyōgo

  • Study site

    Matsuno-shi, Chiba

  • Study site

    Matsuyama, Ehime

  • Study site

    Mebashi-shi, Gunma

  • Study site

    Nihama-shi, Ehime

  • Study site

    Ōita, Oita Prefecture

  • Study site

    Osaka, Osaka

  • Study site

    Sakai-shi, Osaka

  • Study site

    Sapporo, Hokkaido

  • Study site

    Setagaya-ku, Tokyo

  • Study site

    Shinagawa-ku, Tokyo

  • Study site

    Suginami-ku, Tokyo

  • Study site

    tabashi City, Tokyo

  • Study site

    Tondabayashi-shi, Osaka

  • Study site

    Toyama, Toyama

  • Study site

    Yanagigawa-shi, Fukuoka

  • Study site

    Yokohama, Kanagawa

Other trials in Japan

About this study

Official title: A Phase II, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of the Efficacy and Safety of TAK-385 10, 20, and 40 mg (p.o.) in the Treatment of Uterine Fibroids

The purpose of this study is to determine the efficacy and safety of TAK-385, once daily (QD), for 12 weeks in women with uterine fibroids.

Read the detailed description

This study is a Phase II, multicenter, randomized, double-blind, parallel-group, placebo-controlled for evaluation of the efficacy and safety of TAK-385 10, 20, and 40 mg (p.o.) following once daily administration for 12 weeks in women with uterine fibroids.

Being tested
TAK-385, Placebo
Keywords
Drug Therapy
Medical subject headings
Leiomyoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TAK-385Drug

    TAK-385 10 mg, tablets, orally, once daily for up to 12 weeks.

  • TAK-385Drug

    TAK-385 20 mg, tablets, orally, once daily for up to 12 weeks.

  • TAK-385Drug

    TAK-385 40 mg, tablets, orally, once daily for up to 12 weeks.

  • PlaceboDrug

    TAK-385 placebo-matching tablets, orally, once daily for up to 12 weeks.

Study groups in NCT01452659
Study groupRoleWhat they receive
TAK-385 10 mg QDExperimentalNot described
Receives: Drug: TAK-385
TAK-385 20 mg QDExperimentalNot described
Receives: Drug: TAK-385
TAK-385 40 mg QDExperimentalNot described
Receives: Drug: TAK-385
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Decrease in menstrual blood loss

    Blood loss will be assessed using the Pictorial Blood Loss Assessment Chart (PBAC).

    Measured: Week 12 (one menstrual cycle)

Secondary outcomes (20)

  1. Decrease in menstrual blood loss

    Blood loss will be assessed using PBAC

    Measured: Up to Week 6

  2. Decrease in menstrual blood loss

    Blood loss will be assessed using PBAC

    Measured: Up to Week 12.

  3. Amenorrhea

    Amenorrhea will be assessed using PBAC

    Measured: Week 12 (one menstrual cycle).

  4. Amenorrhea

    Amenorrhea will be assessed using PBAC

    Measured: Up to Week 6.

  5. Amenorrhea

    Amenorrhea will be assessed using PBAC

    Measured: Up to Week 12.

  6. Change in menstrual blood loss

    Change in menstrual blood loss measured by PBAC

    Measured: Week 12 (one menstrual cycle)

  7. Myoma Volume

    Measured: Up to Week 12.

  8. Uterine Volume

    Measured: Up to Week 12.

  9. Hemoglobin Concentration in Blood

    Measured: Up to Week 12.

  10. Pain Symptom

    Measured by Numerical Rating Scale.

    Measured: Up to Week 12.

  11. Other Clinical Symptoms

    Assessed by clinical laboratory tests

    Measured: Up to Week 12.

  12. Quality of Life (QOL) Score

    QOL will be assessed using Uterine Fibroid Symptom and Quality of Life (UFS-QOL)

    Measured: Up to Week 12.

  13. Bone Mineral Density

    Measured by Dual-energy X-ray absorptiometry (DXA)

    Measured: Up to Week 12.

  14. Treatment-emergent Adverse Events

    Treatment-emergent adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through the last visit (Week 16)

    Measured: Up to Week 16.

  15. Vital Signs

    Vital signs will include body temperature, sitting blood pressure, and pulse (bpm).

    Measured: Up to Week 12.

  16. Body Weight

    Measured: Up to Week 12.

  17. Electrocardiograms

    Up to Week 12.

  18. Laboratory Values

    Measured: Up to Week 12

  19. Serum NTx

    NTx is one of the biochemical bone metabolism markers

    Measured: Up to Week 12

  20. Serum BAP

    BAP is one of the biochemical bone metabolism markers

    Measured: Up to Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2011 (estimated)
  2. Study startOct 2011
  3. Primary completionSep 2012
  4. Study completionSep 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
216 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01452659
Sponsor's protocol ID
TAK-385/CCT-001
Other IDs
U1111-1123-6815, JapicCTI-111590
Status last verified
Jan 2013
First submitted
31 Aug 2011
Last updated
21 Jan 2013
Results posted
No
Data monitoring committee
No

Publications

  • Hoshiai H, Seki Y, Kusumoto T, Kudou K, Tanimoto M. Relugolix for oral treatment of uterine leiomyomas: a dose-finding, randomized, controlled trial. BMC Womens Health. 2021 Oct 28;21(1):375. doi: 10.1186/s12905-021-01475-2.

    PubMed 34711224

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TAK-385 in people with Uterine Fibroids, run by Takeda at 27 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Decrease in menstrual blood loss (time frame: Week 12 (one menstrual cycle)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01452659, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2013.

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