Medical; Abortion, FetusNCT05940233
Comparison of Rate of Complete Abortion Between Letrozole Plus Misoprostol vs Misoprostol Alone
A study testing Letrozole in people with Medical; Abortion, Fetus, run by Queen Savang Vadhana Memorial Hospital, Thailand at 1 site in Thailand.
Trial summary
Comparison of rate of complete abortion between Letrozole plus Misoprostol versus Misoprostol alone in first trimester pregnancy Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Medical; Abortion, Fetus
- What is being tested?
- Letrozole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteThailand
- Study dates
- 30 Jun 2023to 30 May 2025
- Phase
- Interventional
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diafnoed Early pregnancy loss by TVS according to ACOG Practice bulletin 2018
- GA <= 14 weeks
- Os open <= 1 cm and no conceptus per os
- Hematicrit >= 30
- Systolic blood pressure >= 95 mmHg
- Informed consent done and can follow up and comunicate in Thai language
Who cannot join
- Allerguc to Letrozole or Misoprostol
- Intrauterine contraceptive device use
- Breast feeding
- Diagnoed with ectopic pregnancy or undiagnoed adnexal mass
- Severe or recurrent liver disease or AST or ALT more than or equal to 3 times of upper normal limit
- Multiple pregnancy
Show all 9Show fewer
- Myoma uteri that involves the endometrium ex. Submucous myoma uteri
- Thromboembolism or has a history of thromboembolism
- Serum creatinine >= 2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Rate of Complete Abortion Between Letrozole Plus Misoprostol vs Misoprostol Alone in First Trimester Pregnancy
Comparison of rate of complete abortion between Letrozole plus Misoprostol versus Misoprostol alone in first trimester pregnancy
Read the detailed description
Comparison of rate of complete abortion between Letrozole plus Misoprostol versus Misoprostol alone in first trimester pregnancy; RCT
This reseach focus on the medical abortion in the early pregnancy loss. The target population is 70 patients (35 per group). We devide patient into 2 groups, intervention and control group. In intervention group we give the Letrozole 10 mg PO daily at day 1-3 prior to Misoprostol 800 mcg SL in day 4.
In control group we give only Misoprostol 800 mcg SL. Then, thepatien will follow up on day 7, TVS will be done to diagnose the complete abortion.
The primary outcome is rate of complete abortion between 2 groups. The secondary outcome is side effect of letrozole and induced to abortion time.
- Conditions
- Medical; Abortion, Fetus
- Being tested
- Letrozole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LetrozoleDrug
Also called Femara
In the experimental group, we give the Letrozole 10 mg PO daily on the 4th day before Misoprostol 800 mcg SL on the 4th day. In the control group, we give Misoprostol 800 mcg SL on the 4th day.
| Study group | Role | What they receive |
|---|---|---|
| Letrozole plus Misoprostol | Experimental | We give the Letrozole 10 mg PO daily at day 1-3 prior to Misoprostol 800 mcg SL in day 4. Receives: Drug: Letrozole |
| Misoprostol | Active comparator | We give only Misoprostol 800 mcg SL. Receives: Drug: Letrozole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of complete abortion
Rate of complete abortion
Measured: up to 7 days
Secondary outcomes (2)
Side effect between both group
Number of patients with side effects between both group
Measured: up to 7 days
induced to abortion time between both group
induced to abortion time between both group
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start30 Jun 2023
- Primary completion30 May 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medical; Abortion, FetusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- We devide patient into 2 groups, intervention and control group. In intervention group we give the Letrozole 10 mg PO daily at day 1-3 prior to Misoprostol 800 mcg SL in day 4. In control group we give only Misoprostol 800 mcg SL.
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Savang Vadhana Memorial Hospital, Thailand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ชื่นฤทัย ยี่เขียน, Ph.D., Study chair, Queen Savang Vadhana Memorial Hospital, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05940233
- Sponsor's protocol ID
- 014/2566
- Status last verified
- Aug 2026
- First submitted
- 24 May 2023
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Rate of Complete Abortion Between Letrozole Plus Misoprostol vs Misoprostol Alone in First Trimester Pregnancy
- ClinicalTrials.gov ID
- NCT05940233
- Acronym / sponsor ID
- 014/2566
- Conditions
- Medical; Abortion, Fetus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Queen Savang Vadhana Memorial Hospital, ThailandUniversity, hospital or other
- Study start
- 30 Jun 2023 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 11 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparison of rate of complete abortion between Letrozole plus Misoprostol versus Misoprostol alone in first trimester pregnancy
Detailed description
Comparison of rate of complete abortion between Letrozole plus Misoprostol versus Misoprostol alone in first trimester pregnancy; RCT
This reseach focus on the medical abortion in the early pregnancy loss. The target population is 70 patients (35 per group). We devide patient into 2 groups, intervention and control group. In intervention group we give the Letrozole 10 mg PO daily at day 1-3 prior to Misoprostol 800 mcg SL in day 4.
In control group we give only Misoprostol 800 mcg SL. Then, thepatien will follow up on day 7, TVS will be done to diagnose the complete abortion.
The primary outcome is rate of complete abortion between 2 groups. The secondary outcome is side effect of letrozole and induced to abortion time.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- We devide patient into 2 groups, intervention and control group. In intervention group we give the Letrozole 10 mg PO daily at day 1-3 prior to Misoprostol 800 mcg SL in day 4. In control group we give only Misoprostol 800 mcg SL.
| Arm | Type | Receives |
|---|---|---|
| Letrozole plus Misoprostol | Experimental | Drug: LetrozoleWe give the Letrozole 10 mg PO daily at day 1-3 prior to Misoprostol 800 mcg SL in day 4. |
| Misoprostol | Active comparator | Drug: LetrozoleWe give only Misoprostol 800 mcg SL. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Diafnoed Early pregnancy loss by TVS according to ACOG Practice bulletin 2018
- GA <= 14 weeks
- Os open <= 1 cm and no conceptus per os
- Hematicrit >= 30
- Systolic blood pressure >= 95 mmHg
Key exclusion criteria (9 listed)
- Allerguc to Letrozole or Misoprostol
- Intrauterine contraceptive device use
- Breast feeding
- Diagnoed with ectopic pregnancy or undiagnoed adnexal mass
- Severe or recurrent liver disease or AST or ALT more than or equal to 3 times of upper normal limit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LetrozoleAlso: FemaraIn the experimental group, we give the Letrozole 10 mg PO daily on the 4th day before Misoprostol 800 mcg SL on the 4th day. In the control group, we give Misoprostol 800 mcg SL on the 4th day. | Drug | Letrozole plus Misoprostol, Misoprostol |
Primary outcome
Rate of complete abortion
Time frame: up to 7 days
Rate of complete abortion
2 secondary outcomes
Side effect between both group
Time frame: up to 7 days
induced to abortion time between both group
Time frame: up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ชื่นฤทัย ยี่เขียน, Ph.D. study chair
Queen Savang Vadhana Memorial Hospital, Thailand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Letrozole in people with Medical; Abortion, Fetus, run by Queen Savang Vadhana Memorial Hospital, Thailand at 1 site in Thailand.
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 6 inclusion and 9 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 17 Aug 2026. 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 Thailand. 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. 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?
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?
Rate of complete abortion (time frame: up to 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Aug 2026; AzTrials last refreshed its copy on 7 Nov 2026.