PregnancyPhase 2NCT02457312
The Effect of 7 Days of Letrozole Pretreatment Combined With Misoprostol on the Placental and Decidual Tissues
A Phase 2 study testing Letrozole in people with Pregnancy, run by The University of Hong Kong at 1 site in China.
Trial summary
The present study aims at studying the effect of letrozole in early pregnancy in placenta and decidua including the progesterone receptor and the apoptotic factors. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy
- 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
- 20 participants
- Where
- 1 siteChina
- Study dates
- Mar 2013to Dec 2013
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The gestational age should be up to 63 days. An ultrasound assessment would be performed to confirm the gestation.
- The woman is willing and able to participate after the study has been explained
- Age >18 years old
Who cannot join
- Criteria for prospective exclusion
- Any indication of past or present ill health will be considered a contraindication for recruitment to the study. In particular, subjects should not be recruited if any of the following conditions is present:
- multiple pregnancies
- uterine fibroids
- any significant medical disorder
- intrauterine contraceptive device in situ
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- contra-indications to the use of letrozole or misoprostol
- Criteria for exclusion from a secondary analysis
- Situation in which subjects who have been formally admitted to the study could be excluded from a secondary analysis include:
- the use of drugs other than those prescribed by the investigator for the treatment of possible therapy-related side-effects especially drugs with prostaglandin synthetase inhibitory activity such as salicylates, indomethacin or mefenamic acid
- any violation of the study protocol
- essential data missing from the subject's records making it impossible to judge the treatment outcome
Trial locations and contacts
1 site in 1 country.
About this study
The present study aims at studying the effect of letrozole in early pregnancy in placenta and decidua including the progesterone receptor and the apoptotic factors.
Read the detailed description
Twenty healthy subjects requesting legal surgical abortion up to 63 days gestation will be recruited for this study. They will be randomized to receive either placebo tablets or letrozole 10 mg daily for 7 days before suction evacuation. Suction evacuates which include the placenta and some decidua collected by the procedure in these 20 subjects will be used for the laboratory studies.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LetrozoleDrug
Also called Letrozole group
letrozole 10 mg daily for 7 days before suction evacuation
PlaceboDrug
Also called Placebo group
placebo tablets which look identical to the letrozole tablets for 7 days before suction evacuation
| Study group | Role | What they receive |
|---|---|---|
| Letrozole group | Active comparator | Letrozole 10 mg daily for 7 days before suction evacuation Receives: Drug: Letrozole |
| Placebo group | Placebo comparator | Placebo tablets (look identical to letrozole tablets) daily for 7 days before suction evacuation Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The expression of progesterone receptors and apoptotic factors in the placental and decidual cells by immunostaining.
Measured: 8 days
Secondary outcomes (1)
Apoptosis in the placental and decidual cells as demonstrated by TUNEL assay.
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2015 (estimated)
- Study startMar 2013
- Primary completionMay 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Lee Chi Yan Vivian, Queen Mary Hospital, Hong Kong
- Investigators
- Vivian CY Lee, MBBS, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02457312
- Sponsor's protocol ID
- UW 12-077
- Status last verified
- Dec 2015
- First submitted
- 27 May 2015
- Last updated
- 10 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of 7 Days of Letrozole Pretreatment Combined With Misoprostol on the Placental and Decidual Tissues
- ClinicalTrials.gov ID
- NCT02457312
- Acronym / sponsor ID
- UW 12-077
- Conditions
- Pregnancy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- May 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 29 May 2015 (estimated)
- 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.
The present study aims at studying the effect of letrozole in early pregnancy in placenta and decidua including the progesterone receptor and the apoptotic factors.
Detailed description
Twenty healthy subjects requesting legal surgical abortion up to 63 days gestation will be recruited for this study. They will be randomized to receive either placebo tablets or letrozole 10 mg daily for 7 days before suction evacuation. Suction evacuates which include the placenta and some decidua collected by the procedure in these 20 subjects will be used for the laboratory studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Letrozole group | Active comparator | Drug: LetrozoleLetrozole 10 mg daily for 7 days before suction evacuation |
| Placebo group | Placebo comparator | Drug: PlaceboPlacebo tablets (look identical to letrozole tablets) daily for 7 days before suction evacuation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The gestational age should be up to 63 days. An ultrasound assessment would be performed to confirm the gestation.
- The woman is willing and able to participate after the study has been explained
- Age >18 years old
Key exclusion criteria (12 listed)
- Criteria for prospective exclusion
- Any indication of past or present ill health will be considered a contraindication for recruitment to the study. In particular, subjects should not be recruited if any of the following conditions is present:
- multiple pregnancies
- uterine fibroids
- any significant medical disorder
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: Letrozole groupletrozole 10 mg daily for 7 days before suction evacuation | Drug | Letrozole group |
| PlaceboAlso: Placebo groupplacebo tablets which look identical to the letrozole tablets for 7 days before suction evacuation | Drug | Placebo group |
Primary outcome
The expression of progesterone receptors and apoptotic factors in the placental and decidual cells by immunostaining.
Time frame: 8 days
1 secondary outcome
Apoptosis in the placental and decidual cells as demonstrated by TUNEL assay.
Time frame: 8 days
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 10 Dec 2015.
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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.
Vivian CY Lee, MBBS principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Letrozole in people with Pregnancy, run by The University of Hong Kong at 1 site in China.
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 12 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 10 Dec 2015. 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 China. 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?
The expression of progesterone receptors and apoptotic factors in the placental and decidual cells by immunostaining. (time frame: 8 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 10 Dec 2015.