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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral (A) | Active Comparator | One tablet of Angusta™ (25 µg) or 1/8 of a tablet of Cytotec® (25 µg). |
|
| Oral (B) | Active Comparator | Two tablets of Angusta™ 25 µg or ¼ of a tablet of Cytotec®. |
|
| Sublingual (C) | Active Comparator | Two tablets of Angusta™ (total dose of 50 µg) or ¼ of a tablet of Cytotec® (50 µg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Angusta™ | Drug | One tablet of Angusta™ (25 µg) given every 2 hours |
| |
| Measure | Description | Time Frame |
|---|---|---|
| AUC (area under the curve) 0-t misoprostol | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| t max (Time to maximum) of misoprostol | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dag Wide-Swensson | Region Skane | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skåne University Hospital Lund | Lund | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32116725 | Derived | 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. |
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| ID | Term |
|---|---|
| D016595 | Misoprostol |
| ID | Term |
|---|---|
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
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| 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. |
|
| 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 | At time of birth |
| Cardiotochographic (CTG) monitoring. | During labour |
| Adverse event / Serious Adverse event profile. | From screening and until 7 days post treatment. |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |