Is Cerazette Use Before Nexplanon Insertion Predictive for Bleeding Pattern?
This study is not yet open for participant recruitment.
Verified September 2011 by VL-Medi Oy
Sponsor:
VL-Medi Oy
Collaborator:
Merck
Information provided by (Responsible Party):
VL-Medi Oy
ClinicalTrials.gov Identifier:
NCT01438736
First received: September 20, 2011
Last updated: September 21, 2011
Last verified: September 2011
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Purpose
The purpose of the study is to examine how well three months preceding use of Cerazette progestin only pill predicts the bleeding pattern during following Nexplanon implant use.
| Condition | Intervention | Phase |
|---|---|---|
|
Bleeding |
Drug: Desogestrel 75 micrograms POP (Cerazette), Etonogestrel 68 mg implant (Nexplanon) Drug: Etonogestrel 68 mg subdermal implant |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | A Randomized Study to Evaluate the Predictive Impact of Using Cerazette Progestin Only Pill Before Nexplanon Insertion Regarding Bleeding Pattern |
Resource links provided by NLM:
Further study details as provided by VL-Medi Oy:
Primary Outcome Measures:
- The total number of bleeding days per 90 days reference period in women using Cerazette before Nexplanon and in women starting Nexplanon without preceding POP [ Time Frame: 9 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- The number of bleeding episodes according to WHO definitions [ Time Frame: 9 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 90 |
| Study Start Date: | September 2011 |
| Estimated Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Desogestrel, Etonogestrel
Arm 1: 75 microgr desogestrel POP (cerazette) daily for 3 months followed by etonogestrel implant (Nexplanon, 68 mg etonogestrel) for following 6 months
|
Drug: Desogestrel 75 micrograms POP (Cerazette), Etonogestrel 68 mg implant (Nexplanon)
Desogestrel 75 micrograms POP daily for 3 monts, followed by etonogestrel 68 mg subdermal implant for following 6 months
|
|
Experimental: Etonogestrel
Arm 2: Women staring straight with Nexplanon implant for 6 months
|
Drug: Etonogestrel 68 mg subdermal implant
Etonogestrel 68 mg subdermal implant for 6 months
|
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy women, 18-40 years of age
- regular menstrual cycle (period 23-35 days)
Exclusion Criteria:
- -Immediate previous use of progestin only contraception within 2 months
- Known or suspected pregnancy
- Acute tromboembolic disorder
- Presence or history of hepatic disease, as long as the liver function values have not returned to normal
- Undiagnosed vaginal bleeding
- Known or suspected sex-steroid influenced malignancies (e.g. breast cancer)
- Hypersensitivity to the active substances or to any of the excipients of the medicines
- Pregnant or breast feeding within 6 weeks
- The use of other medicinal products that might interact with contraceptive steroids and affect the efficacy of contraceptives and/or might may lead to bleeding irregularities (especially medicines that induce the liver enzyme systems such as cytochrome P450). Examples of active substances are: phenytoin, phenobarbital, primidone, bosentan, carbamatzepine, rifampicin and medicinal products or herbal preparations containing ST.John's wort and to a lesser extend oxcarbazepine, topiramate, felbamate and griseofulvin.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01438736
Contacts
| Contact: Dan Apter, Docent | +358405550842 | dan.apter@vaestoliitto.fi |
Locations
| Finland | |
| VL Medi Oy | Not yet recruiting |
| Helsinki, Finland, 00101 | |
| Principal Investigator: Dan Apter, docent | |
Sponsors and Collaborators
VL-Medi Oy
Merck
Investigators
| Principal Investigator: | Dan Apter, Docent | VL-Medi Oy |
More Information
No publications provided
| Responsible Party: | VL-Medi Oy |
| ClinicalTrials.gov Identifier: | NCT01438736 History of Changes |
| Other Study ID Numbers: | EudraCT 2011-001492-39, IIPS#39689 |
| Study First Received: | September 20, 2011 |
| Last Updated: | September 21, 2011 |
| Health Authority: | Finland: HUS Ethics Committee Finland: Finnish Medicines Agency FIMEA |
Keywords provided by VL-Medi Oy:
|
Focus: preceding desogestrel predicts pattern of following etonogestrel implant |
Additional relevant MeSH terms:
|
Hemorrhage Pathologic Processes 3-keto-desogestrel Desogestrel Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs |
Pharmacologic Actions Therapeutic Uses Progestins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Contraceptives, Oral, Synthetic Contraceptives, Oral |
ClinicalTrials.gov processed this record on June 17, 2013