AzTrials
AzTrials

Endometriotic Cyst of OvaryNCT05487092

Letrozole in Preventing Recurrence of Endometrioma Following Laparoscopic Ovarian Cystectomy

A study testing Letrozole in people with Endometriotic Cyst of Ovary, run by The University of Hong Kong at 5 sites in Hong Kong.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Endometriosis is a chronic inflammatory disease that affects approximately 10-15% of women of reproductive age. Symptoms include dysmenorrhoea, chronic pelvic pain, dyspareunia and infertility. Removal of the endometriotic cyst (chocolate cyst) by surgery is a well-established treatment for symptomatic relief. Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Endometriotic Cyst of Ovary
What is being tested?
Letrozole
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
194 participants
Where
5 sitesHong Kong
Study dates
1 Dec 2022to 30 Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Women aged 18-45 years old
  • Scheduled to have laparoscopic ovarian cystectomy
  • Unilateral or bilateral endometrioma on pre-operative ultrasound and confirmed by histology

Who cannot join

  • Use of long-acting hormonal therapy in the 3 months before inclusion in the study
  • Histological report of laparoscopic ovarian cystectomy showed atypical endometrioma
  • Complex surgery including resection of deep infiltrating disease, bowel resection or hysterectomy
  • Incomplete excision of endometrioma/ incision or drainage rather than ovarian cystectomy
  • Suspicion of malignancy
  • Contraindications to combined oral contraceptive pills, including: uncontrolled hypertension (systolic > 160mmHg or diastolic > 100mmHg), diabetes with retinopathy/ nephropathy/ neuropathy, current or past history of venous thromboembolism, ischemic heart disease, history of cerebrovascular accident, migraine with aura, severe liver disease, oestrogen-sensitive cancers, undiagnosed abnormal uterine bleeding, smokers (> 15 cigarettes/day) aged 35 years or above, or having body mass index >=35 kg/m2
  • Planning to get pregnant in the coming 1 year
  • Refusal to join the study

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

5 sites in 1 country

Hong Kong5 sites, 5 recruiting

  • Queen Mary Hospital

    Hong Kong, 000000

    Jennifer K.Y. Ko, MBBS, MRCOG, 22554647, jenko@hku.hk

    Recruiting

  • Kwong Wah Hospital

    Hong Kong

    Mei Ting Lam, MBBS

    Not yet recruiting

  • Pamela Youde Nethersole Eastern Hospital

    Hong Kong

    Catherine K.Y. Wong

    Not yet recruiting

  • Princess Margaret Hospital

    Hong Kong

    Rebecca S.F. Wan, MBBS, MRCOG

    Not yet recruiting

  • Queen Elizabeth Hospital

    Hong Kong

    Keedon Wong

    Not yet recruiting

Other trials in Hong Kong

About this study

Endometriosis is a chronic inflammatory disease that affects approximately 10-15% of women of reproductive age. Symptoms include dysmenorrhoea, chronic pelvic pain, dyspareunia and infertility. Removal of the endometriotic cyst (chocolate cyst) by surgery is a well-established treatment for symptomatic relief. However, recurrence of endometriotic cyst after surgical removal of the cyst is up to 30-50% after ovarian surgery. Oral contraceptive pills for 18-24 months after the surgery is widely used as a postoperative hormonal therapy because it has been shown to reduce the chance of recurrence of the endometriotic cyst, but recurrence is still high even after taking oral contraceptive pills.

Letrozole is an aromatase inhibitor. There are some preliminary reports that letrozole can cause shrinkage of endometriotic cysts and improve endometriosis-related pelvic pain by reducing oestrogen level, inflammation and stem cell recruitment that may be important in recurrence of endometriotic cyst. This is a randomized double-blinded placebo-controlled trial. The aim of this study is to assess whether taking letrozole in addition to oral contraceptive pills in the first 6 months after laparoscopic surgery (key-hole surgery) to remove the endometriotic cyst can reduce the risk of recurrence compared to oral contraceptive pills alone. The study also involves laboratory parts from a small portion of the endometriotic cyst specimens (removed during laparoscopy ovarian cystectomy) and endometrial biopsy (if the patient agrees) to assess the role of stem cells in the pathogenesis of endometriotic cysts.

Being tested
Letrozole, Placebo
Keywords
endometriotic cyst, recurrence, letrozole, combined oral contraceptive pills
Medical subject headings
Endometriosis, Recurrence

What participants receive

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

  • LetrozoleDrug

    Letrozole 2.5mg daily for 6 months

  • PlaceboOther

    Placebo

Study groups in NCT05487092
Study groupRoleWhat they receive
LetrozoleExperimentalThey will be given letrozole 2.5mg daily on top of combined oral contraceptive (COC) pills (Microgynon 30, which contains 30mcg ethinyloestradiol and 150 mcg levonorgestrel) orally for 6 months after laparoscopic ovarian cystectomy, followed by COC pills alone subsequently as routine
Receives: Drug: Letrozole
Standard treatmentPlacebo comparatorThey will be given placebo tablets (which will be identical to letrozole) on top of COC pills (Microgynon 30, which contains 30mcg ethinyloestradiol and 150 mcg levonorgestrel) orally for 6 months after laparoscopic ovarian cystectomy, followed by COC pills alone subsequently
Receives: Other: Placebo

What is being measured

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

  1. Recurrence of endometrioma

    the presence of ovarian cysts with the typical sonographic criteria of endometriomas and a diameter of ≥30 mm after previous complete ovarian cystectomy, to be measured by a transvaginal or transrectal ultrasound transducer

    Measured: 12 months

Secondary outcomes (6)

  1. Endometriosis Health Profile Questionnaire (EHP-30) score

    a validated disease-specific health related quality of life patient self-reported scale for endometriosis used to measure the effects that endometriosis can have on the women's lives and the effectiveness of medical and surgical therapies for endometriosis on their quality of life

    Measured: 6 months, 12 months, 24 months

  2. Non-menstrual pelvic pain (chronic pelvic pain, deep dyspareunia) and dysmenorrhoea measured by a 10cm visual analogue pain scale (VAS)

    0-100

    Measured: 6 months, 12 months, 24 months

  3. Menstrual regularity

    menstrual chart

    Measured: 6 months, 12 months, 24 months

  4. Use of additional analgesics

    Measured: 6 months, 12 months, 24 months

  5. Side effects/ adverse events

    Number of women with side effects/ adverse events

    Measured: 6 months, 12 months, 24 months

  6. Need for further surgery for endometriosis

    Number of women who required further surgery for endometriosis

    Measured: 6 months, 12 months, 24 months

Timeline

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

  1. First posted4 Aug 2022
  2. Study start1 Dec 2022
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion30 Jun 2027 (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 N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
194 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05487092
Sponsor's protocol ID
UW21-556
Status last verified
May 2024
First submitted
2 Aug 2022
Last updated
14 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Letrozole in people with Endometriotic Cyst of Ovary, run by The University of Hong Kong at 5 sites 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 3 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites 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.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recurrence of endometrioma (time frame: 12 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 NCT05487092.

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 14 May 2024.

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