AzTrials
AzTrials

Tubal PregnancyPhase 3NCT04341545

Letrozole in Tubal Ectopic Pregnancy

A Phase 3 study testing Letrozole tablets in people with Tubal Pregnancy, run by Queen Mary Hospital, Hong Kong at 1 site in Hong Kong.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

This is a multi-centred randomized controlled trial on the addition of letrozole in the medical management of tubal ectopic pregnancies. Tubal ectopic pregnancies are abnormal pregnancies in the Fallopian tube, rather than in the womb. They occurred in around 1-2% of all pregnancies. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Tubal Pregnancy
What is being tested?
Letrozole tablets
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
214 participants
Where
1 siteHong Kong
Study dates
1 Dec 2020to 31 Mar 2025
Phase
Phase 3
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 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Presence of heterogenous adnexal mass on USG suggestive of tubal ectopic pregnancy with hCG level >=1500 IU/L and <= 5000 IU/L
  • Absence of fetal heart pulsation
  • Mean diameter of adnexal mass <= 3.5cm
  • Haemodynamically stable
  • No significant abdominal pain

Who cannot join

  • Presence of significant amount of free fluid in pelvis
  • Allergic to MTX
  • Deranged liver function test (AST/ ALT or GGT >= 2 upper limit of normal)
  • Deranged renal function test (eGFR <= 45ml/min)
  • Heterotopic pregnancies

Trial locations and contacts

1 site in 1 country.

Evelyn Wong, MBBS contact

22554517

evelynwong.ew@gmail.com

Hong Kong1 site, 1 recruiting

  • Department of Obstetrics and Gynaecology, Queen Mary Hospital

    Hong Kong

    Karen Chan, Prof, 22554647, kklchan@hku.hk

    Recruiting

Other trials in Hong Kong

About this study

Official title: Randomized Controlled Trial on Use of Letrozole in the Medical Management of Tubal Ectopic Pregnancies

This is a multi-centred randomized controlled trial on the addition of letrozole in the medical management of tubal ectopic pregnancies.

Tubal ectopic pregnancies are abnormal pregnancies in the Fallopian tube, rather than in the womb. They occurred in around 1-2% of all pregnancies. Methotrexate (MTX) given by the intramuscular route i.e. systemic, a commonly used drug for cancer , was a widely used alternative for management for unruptured tubal ectopic pregnancies and was recommended as first line treatment for selected women.

Read more

Letrozole, aromatase inhibitor, can suppose oestradiol level. Combination of letrozole with misprostol has shown to improve the complete abortion rate in miscarriage. As a result, addition of letrozole may cause a higher success rate in the medical treatment of ectopic pregnancy.

As the evidence of combination of MTX and letrozole in tubal ectopic pregnancies is not available, the objective of the present study is to evaluate the efficacy of combination of MTX and letrozole compared to MTX alone in women with tubal ectopic pregnancies.

Read the detailed description

Tubal ectopic pregnancies occur in around 1-2% of all pregnancies. Traditionally, surgery with salpingectomy was the mainstay of treatment; however, it comes with anaesthetic and operatives risks in addition to an increased cost for operative procedures. In recent years, systemic methotrexate (MTX), a dihydrofolate reductase inhibitor, has been a widely used alternative for management for unruptured tubal ectopic pregnancies. The success rate of systemic MTX at a doses of 50mg/m2 body surface area is around 70% which ranges from 65 to 95%, depending greatly on the level of human chorionic gonadotrophin (hCG), the size of adnexal mass and presence of fetal heart pulsation.

Use of systemic MTX as the first-line management has been proposed for women with unruptured ectopic pregnancy where the adnexal mass is smaller than 35mm, serum hCG level is less than 5000 IU/l and fetal heartbeat is absent.

Letrozole is a third generation non-steroidal reversible aromatase inhibitor. It can suppress oestradiol level up to 95% to 99% after administration according to pharmacodynamics and pharmacokinetics studies. Oestrogen is important in the support of early pregnancy, other than progesterone with well-known pivotal effect on the maintenance of early pregnancy.

Animal studies showed the combination of mifepristone and letrozole worked synergistically and induced almost 100% termination of pregnancies in rats. Letrozole induced 50% miscarriage rate in pregnant baboons. Letrozole combined with vaginal misoprostol regimen was associated with a higher complete abortion rate than misoprostol alone in pregnancies up to 63 days.

The use of letrozole in ectopic pregnancy has never been explored. It is hypothesized that letrozole can suppress serum oestradiol level, which in turn, may cause failure of pregnancy in ectopic pregnancy. The aim of this study is to investigate the clinical effectiveness of letrozole in addition to MTX in the medical treatment of ectopic pregnancy.

Conditions
Tubal Pregnancy
Being tested
Placebos, Letrozole tablets
Keywords
Tubal ectopic pregnancy, Methotrexate, Letrozole
Medical subject headings
Pregnancy, Tubal

What participants receive

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

  • PlacebosOther

    Placebo 4 tablets a day for one week.

  • Letrozole tabletsDrug

    Also called Letrozole

    Letrozole 10mg daily for one week.

Study groups in NCT04341545
Study groupRoleWhat they receive
LetrozoleExperimentalParticipants will be given letrozole 10mg daily for one week after standard medical management for tubal ectopic pregnancy by methotrexate injection. Subsequently they will receive the standard management for medical management of tubal ectopic prengnacies.
Receives: Drug: Letrozole tablets
PlaceboPlacebo comparatorParticipants will be given identical looking placebo for one week and receive the same standard management for medical management of tubal ectopic pregnancies.
Receives: Other: Placebos

What is being measured

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

  1. Treatment success

    Proportion of women with treatment success defined as normalization of serum hCG level <10IU/L without additional medical or surgical intervention

    Measured: 2 months

Secondary outcomes (4)

  1. hCG normalization duration

    Duration of time until hCG normalization measured in days

    Measured: 2 months

  2. Number of participants experienced side effects

    Side effects after letrozole

    Measured: 2 months

  3. Duration of hospitalization

    Duration of hospitalization

    Measured: 2 months

  4. Participant satisfaction: proportion of women who would recommend this treatment to a friend

    Treatment satisfaction measured as proportion of women who would recommend this treatment to a friend

    Measured: 2 months

Timeline

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

  1. First posted10 Apr 2020
  2. Study start1 Dec 2020
  3. Primary completion30 Dec 2024 (estimated)
  4. Study completion31 Mar 2025 (estimated)

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomized into either receive letrozole or placebo capsules.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
214 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04341545
Sponsor's protocol ID
UW 20-005
Status last verified
Apr 2023
First submitted
7 Apr 2020
Last updated
10 Apr 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Other researchers may contact the chief investigator for the request of individual participant data.

Publications

  • Panelli DM, Phillips CH, Brady PC. Incidence, diagnosis and management of tubal and nontubal ectopic pregnancies: a review. Fertil Res Pract. 2015 Oct 15;1:15. doi: 10.1186/s40738-015-0008-z. eCollection 2015.

    PubMed 28620520

  • Diagnosis and Management of Ectopic Pregnancy: Green-top Guideline No. 21. BJOG. 2016 Dec;123(13):e15-e55. doi: 10.1111/1471-0528.14189. Epub 2016 Nov 3. No abstract available.

    PubMed 27813249

  • Odejinmi F, Huff KO, Oliver R. Individualisation of intervention for tubal ectopic pregnancy: historical perspectives and the modern evidence based management of ectopic pregnancy. Eur J Obstet Gynecol Reprod Biol. 2017 Mar;210:69-75. doi: 10.1016/j.ejogrb.2016.10.037. Epub 2016 Oct 29.

    PubMed 27940397

  • National Collaborating Centre for Ws, Children's H. National Institute for Health and Clinical Excellence: Guidance. Ectopic Pregnancy and Miscarriage: Diagnosis and Initial Management in Early Pregnancy of Ectopic Pregnancy and Miscarriage. London: Rcog National Collaborating Centre for Women's and Children's Health.; 2012.

  • Shi L, Shi SQ, Given RL, von Hertzen H, Garfield RE. Synergistic effects of antiprogestins and iNOS or aromatase inhibitors on establishment and maintenance of pregnancy. Steroids. 2003 Nov;68(10-13):1077-84. doi: 10.1016/j.steroids.2003.09.002.

    PubMed 14668001

  • Albrecht ED, Aberdeen GW, Pepe GJ. The role of estrogen in the maintenance of primate pregnancy. Am J Obstet Gynecol. 2000 Feb;182(2):432-8. doi: 10.1016/s0002-9378(00)70235-3.

    PubMed 10694348

  • Lee VCY, Ng EHY, Yeung WSB, Ho PC. Misoprostol with or without letrozole pretreatment for termination of pregnancy: a randomized controlled trial. Obstet Gynecol. 2011 Feb;117(2 Pt 1):317-323. doi: 10.1097/AOG.0b013e3182073fbf.

    PubMed 21252745

  • Lee VC, Tang OS, Ng EH, Yeung WS, Ho PC. A pilot study on the use of letrozole with either misoprostol or mifepristone for termination of pregnancy up to 63 days. Contraception. 2011 Jan;83(1):62-7. doi: 10.1016/j.contraception.2010.05.014. Epub 2010 Jun 23.

    PubMed 21134505

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Letrozole tablets in people with Tubal Pregnancy, run by Queen Mary Hospital, Hong Kong at 1 site in Hong Kong.

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 5 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: status not confirmed, as of the sponsor's last update on 10 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Results are not available in the source record.

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

Contact Evelyn Wong, MBBS (22554517, evelynwong.ew@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment success (time frame: 2 months). 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 NCT04341545, which also lists 8 linked publications.

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 10 Apr 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in