Labour, InducedPhase 1NCT02516631
Comparative Bioavailability Study of Two Misoprostol Formulations
A Phase 1 study testing Angusta™ and Cytotec® in people with Labour, Induced, run by Region Skane at 1 site in Sweden.
Trial summary
The purpose of this study is to compare pharmacokinetics of two formulations of misoprostol following single dose administration in adult women being given misoprostol for cervical ripening and induction of labour. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Labour, Induced
- What is being tested?
- Angusta™ and Cytotec®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2014to Feb 2016
- Phase
- Phase 1
- 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
- Adult females
- Women wanting to participate and having given informed consent
- Known to have reached week 37 + 0 days to week 42 + 2 days of gestation
- With a viable fetus in a vertex position
- Age above or equal to 18 years old
- Women opting for vaginal delivery
- BMI between 20 and 30 kg/m2
Who cannot join
- Women with known allergy to misoprostol or other prostaglandins
- Women with prior caesarean section
- Women with dead or anomalous fetus
- Women with twin pregnancy
- Women with known liver or renal dysfunction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative, Open-label, Parallel Design, Bioavailability Study of Two Misoprostol Formulations (Angusta™ 25 µg Dispersible Tablets vs. Cytotec® 200 µg Tablets) Following Single Oral or Sublingual Administration and Comparison of Safety of the Two Formulations Following Repeat Dosing Until Labour
The purpose of this study is to compare pharmacokinetics of two formulations of misoprostol following single dose administration in adult women being given misoprostol for cervical ripening and induction of labour.
Read the detailed description
Prostaglandin E2 (dinoprostone) given vaginally or intra-cervically, and oxytocin have been the most commonly used preparations for induction of labour. Misoprostol is a synthetic prostaglandin E1 analogue. Misoprostol has anti-secretory and mucosal protective properties and was originally developed in the 1970s for the prevention of nonsteroidal anti-inflammatory drug (NSAID)-induced peptic ulcers. It is now used much more widely for 'off-label' indications like medication abortion, medical management of miscarriage, cervical ripening before surgical procedures, treatment of postpartum hemorrhage, and induction of labour. The lack of a specific license for Cytotec® to be used in obstetrics and gynecology has led to a number of problems regarding correct dose and dose regime.
The study is an open-label, randomized, single-dose, comparative, parallel design, bioavailability study followed by repeat dosing of of two formulations misoprostol in healthy adult females being induced to go into labour.
The drug shall be administered orally or sublingually.
- Conditions
- Labour, Induced
- Being tested
- Angusta™, Cytotec®
- Keywords
- Labour, induced, Misoprostol, Pharmacokinetics, Cardiotocography, Safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angusta™Drug
One tablet of Angusta™ (25 µg) given every 2 hours
Cytotec®Drug
1/8 of a tablet of Cytotec® (25 µg) given every 2 hours. Drug administration should be repeated every 2 hours until labour has commenced.
Angusta™Drug
Two tablets of Angusta™ 25 µg given every 4 hours
Cytotec®Drug
¼ of a tablet of Cytotec® given every 4 hours. Drug administration should be repeated every 4 hours until labour has commenced.
Angusta™Drug
Two tablets of Angusta™ (total dose of 50 µg), given every 4 hours
Cytotec®Drug
¼ of a tablet of Cytotec® (50 µg), given every 4 hours. Subjects should not swallow for a period of 5 minutes. Drug administration should be repeated every 4 hours until labour has commenced.
| Study group | Role | What they receive |
|---|---|---|
| Oral (A) | Active comparator | One tablet of Angusta™ (25 µg) or 1/8 of a tablet of Cytotec® (25 µg). Receives: Drug: Angusta™; Drug: Cytotec® |
| Oral (B) | Active comparator | Two tablets of Angusta™ 25 µg or ¼ of a tablet of Cytotec®. Receives: Drug: Angusta™; Drug: Cytotec® |
| Sublingual (C) | Active comparator | Two tablets of Angusta™ (total dose of 50 µg) or ¼ of a tablet of Cytotec® (50 µg. Receives: Drug: Angusta™; Drug: Cytotec® |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC (area under the curve) 0-t misoprostol
Measured: For 2 hours regime: pre-dose, 5, 10, 20, 30, 40, 50, 75, 100 and 120 min post-dose. For 4-hours regime at pre-dose, 5, 10, 20, 30, 40, 50, 75, 100,120, 180 and 240 min post-dose
AUC (area under the curve) 0-inf of misoprostol
Measured: For 2 hours regime: pre-dose, 5, 10, 20, 30, 40, 50, 75, 100 and 120 min post-dose. For 4-hours regime at pre-dose, 5, 10, 20, 30, 40, 50, 75, 100,120, 180 and 240 min post-dose
Secondary outcomes (5)
t max (Time to maximum) of misoprostol
Measured: For 2 hours regime: pre-dose, 5, 10, 20, 30, 40, 50, 75, 100 and 120 min post-dose. For 4-hours regime at pre-dose, 5, 10, 20, 30, 40, 50, 75, 100,120, 180 and 240 min post-dose
t 1/2 (Elimination half-life) of misoprostol
Measured: For 2 hours regime: pre-dose, 5, 10, 20, 30, 40, 50, 75, 100 and 120 min post-dose. For 4-hours regime at pre-dose, 5, 10, 20, 30, 40, 50, 75, 100,120, 180 and 240 min post-dose
APGAR score of infant
Measured: At time of birth
Cardiotochographic (CTG) monitoring.
Measured: During labour
Adverse event / Serious Adverse event profile.
Measured: From screening and until 7 days post treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2015 (estimated)
- Study startNov 2014
- Primary completionNov 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Labour, InducedStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dag Wide-Swensson, Principal investigator, Region Skane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02516631
- Sponsor's protocol ID
- AZ-201
- Status last verified
- Dec 2016
- First submitted
- 12 Jun 2015
- Last updated
- 6 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Amini M, Reis M, Wide-Swensson D. A Relative Bioavailability Study of Two Misoprostol Formulations Following a Single Oral or Sublingual Administration. Front Pharmacol. 2020 Feb 12;11:50. doi: 10.3389/fphar.2020.00050. eCollection 2020.
PubMed 32116725
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative, Open-label, Parallel Design, Bioavailability Study of Two Misoprostol Formulations (Angusta™ 25 µg Dispersible Tablets vs. Cytotec® 200 µg Tablets) Following Single Oral or Sublingual Administration and Comparison of Safety of the Two Formulations Following Repeat Dosing Until Labour
- ClinicalTrials.gov ID
- NCT02516631
- Acronym / sponsor ID
- AZ-201
- Conditions
- Labour, Induced
- Keywords
- Labour, induced, Misoprostol, Pharmacokinetics, Cardiotocography, Safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 6 Aug 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 purpose of this study is to compare pharmacokinetics of two formulations of misoprostol following single dose administration in adult women being given misoprostol for cervical ripening and induction of labour.
Detailed description
Prostaglandin E2 (dinoprostone) given vaginally or intra-cervically, and oxytocin have been the most commonly used preparations for induction of labour. Misoprostol is a synthetic prostaglandin E1 analogue. Misoprostol has anti-secretory and mucosal protective properties and was originally developed in the 1970s for the prevention of nonsteroidal anti-inflammatory drug (NSAID)-induced peptic ulcers. It is now used much more widely for 'off-label' indications like medication abortion, medical management of miscarriage, cervical ripening before surgical procedures, treatment of postpartum hemorrhage, and induction of labour. The lack of a specific license for Cytotec® to be used in obstetrics and gynecology has led to a number of problems regarding correct dose and dose regime.
The study is an open-label, randomized, single-dose, comparative, parallel design, bioavailability study followed by repeat dosing of of two formulations misoprostol in healthy adult females being induced to go into labour.
The drug shall be administered orally or sublingually.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oral (A) | Active comparator | Drug: Angusta™, Drug: Cytotec®One tablet of Angusta™ (25 µg) or 1/8 of a tablet of Cytotec® (25 µg). |
| Oral (B) | Active comparator | Drug: Angusta™, Drug: Cytotec®Two tablets of Angusta™ 25 µg or ¼ of a tablet of Cytotec®. |
| Sublingual (C) | Active comparator | Drug: Angusta™, Drug: Cytotec®Two tablets of Angusta™ (total dose of 50 µg) or ¼ of a tablet of Cytotec® (50 µg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult females
- Women wanting to participate and having given informed consent
- Known to have reached week 37 + 0 days to week 42 + 2 days of gestation
- With a viable fetus in a vertex position
- Age above or equal to 18 years old
Key exclusion criteria (5 listed)
- Women with known allergy to misoprostol or other prostaglandins
- Women with prior caesarean section
- Women with dead or anomalous fetus
- Women with twin pregnancy
- Women with known liver or renal dysfunction
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 |
|---|---|---|
| Angusta™One tablet of Angusta™ (25 µg) given every 2 hours | Drug | Oral (A) |
| Cytotec®1/8 of a tablet of Cytotec® (25 µg) given every 2 hours. Drug administration should be repeated every 2 hours until labour has commenced. | Drug | Oral (A) |
| Angusta™Two tablets of Angusta™ 25 µg given every 4 hours | Drug | Oral (B) |
| Cytotec®¼ of a tablet of Cytotec® given every 4 hours. Drug administration should be repeated every 4 hours until labour has commenced. | Drug | Oral (B) |
| Angusta™Two tablets of Angusta™ (total dose of 50 µg), given every 4 hours | Drug | Sublingual (C) |
| Cytotec®¼ of a tablet of Cytotec® (50 µg), given every 4 hours. Subjects should not swallow for a period of 5 minutes. Drug administration should be repeated every 4 hours until labour has commenced. | Drug | Sublingual (C) |
Primary outcome
AUC (area under the curve) 0-t misoprostol
Time frame: For 2 hours regime: pre-dose, 5, 10, 20, 30, 40, 50, 75, 100 and 120 min post-dose. For 4-hours regime at pre-dose, 5, 10, 20, 30, 40, 50, 75, 100,120, 180 and 240 min post-dose
AUC (area under the curve) 0-inf of misoprostol
Time frame: For 2 hours regime: pre-dose, 5, 10, 20, 30, 40, 50, 75, 100 and 120 min post-dose. For 4-hours regime at pre-dose, 5, 10, 20, 30, 40, 50, 75, 100,120, 180 and 240 min post-dose
5 secondary outcomes
t max (Time to maximum) of misoprostol
Time frame: For 2 hours regime: pre-dose, 5, 10, 20, 30, 40, 50, 75, 100 and 120 min post-dose. For 4-hours regime at pre-dose, 5, 10, 20, 30, 40, 50, 75, 100,120, 180 and 240 min post-dose
t 1/2 (Elimination half-life) of misoprostol
Time frame: For 2 hours regime: pre-dose, 5, 10, 20, 30, 40, 50, 75, 100 and 120 min post-dose. For 4-hours regime at pre-dose, 5, 10, 20, 30, 40, 50, 75, 100,120, 180 and 240 min post-dose
APGAR score of infant
Time frame: At time of birth
Cardiotochographic (CTG) monitoring.
Time frame: During labour
Adverse event / Serious Adverse event profile.
Time frame: From screening and until 7 days post treatment.
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 6 Dec 2016.
- Derived from this study: PubMed 32116725Amini M, Reis M, Wide-Swensson D. A Relative Bioavailability Study of Two Misoprostol Formulations Following a Single Oral or Sublingual Administration. Front Pharmacol. 2020 Feb 12;11:50. doi: 10.3389/fphar.2020.00050. eCollection 2020.
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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.
Dag Wide-Swensson principal investigator
Region Skane
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Angusta™ and Cytotec® in people with Labour, Induced, run by Region Skane at 1 site in Sweden.
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 7 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: finished, as of the sponsor's last update on 6 Dec 2016. 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 Sweden. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
AUC (area under the curve) 0-t misoprostol (time frame: For 2 hours regime: pre-dose, 5, 10, 20, 30, 40, 50, 75, 100 and 120 min post-dose. For 4-hours regime at pre-dose, 5, 10, 20, 30, 40, 50, 75, 100,120, 180 and 240 min post-dose). The study lists 2 primary outcomes in all. 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 NCT02516631, 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 6 Dec 2016.