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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01384331




Registration number
NCT01384331
Ethics application status
Date submitted
27/06/2011
Date registered
29/06/2011
Date last updated
29/06/2011

Titles & IDs
Public title
New Treatments for Troublesome Bleeding in Implanon Users
Scientific title
Phase 4 Study Comparison of Two Combined Oral Contraceptive Regimens and an Intravaginal Hormonal Ring Against Placebo for Management of Bleeding Problems in Women Using Implanon, the Sub-dermal Contraceptive Implant
Secondary ID [1] 0 0
ACTRN12611000617965
Secondary ID [2] 0 0
R2011-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Menstrual Problem 0 0
Condition category
Condition code
Reproductive Health and Childbirth 0 0 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Marvelon

Active Comparator: Group 1 Marvelon ,placebo - 7 days daily intake of oral capsule containing "Marvelon" ethinyl oestradiol 30micrograms plus desogestrel 150 micrograms followed by 14 days oral placebo capsules containing starch for 21 day treatment Cycle

Active Comparator: Marvelon - 21 days daily intake of oral capsules containing ethinyl oestradiol 30micrograms plus desogestrel 150 micrograms
for one cycle of 21 days

Active Comparator: NuvaRing - 21 days NuvaRing contraceptive vaginal ring releasing ethinyl oestradiol 15micrograms plus etonorgestrel 120 micrograms dailyleft in situ for 21 days Treatment will be for 21 days

Placebo Comparator: Starch capsule - 21 days daily oral placebo capsules Treatment will be for one 21 day cycle


Treatment: Drugs: Marvelon
7 days daily intake of oral capsule containing containing ethinyl oestradiol 30micrograms plus desogestrel 150 micrograms followed by 14 days oral placebo capsules
21 days daily intake of oral capsules containing ethinyl oestradiol 30micrograms plus desogestrel 150 micrograms
21 days NuvaRing contraceptive vaginal ring releasing ethinyl oestradiol 15micrograms plus etonorgestrel 120 micrograms dailyleft in situ for 21 days
21 days daily oral placebo capsules Treatment will be for one cycle of 21 days

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The number of days to stop bleeding after initiation of each treatment group and placebo - The number of days to stop bleeding after initiation of each treatment group and placebo determined from menstrual diaries completed by subjects
Timepoint [1] 0 0
Within 3 weeks of starting therapy
Secondary outcome [1] 0 0
The mean total number of bleeding and spotting days during the 90 day "treatment" reference period - The mean total number of bleeding and spotting days during the 90 day "treatment" reference period compared with the pre-treatment reference period (calculated as percentage reduction) for each group and a comparison between treatment groups and placebo and compared to the other treatment groups determined from menstrual diaries kept for 90 days prior to starting treatment and for 90 days from initiation of treatment.
Timepoint [1] 0 0
Six months after entering study

Eligibility
Key inclusion criteria
- Healthy women aged 18-45 using the subdermal progestogen-only contraceptive implant
and experiencing frequent or prolonged vaginal bleeding Willing to keep a menstrual
diary for 6 months
Minimum age
18 Years
Maximum age
45 Years
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Women who have currently or previously had

- Heart attack or stroke

- Blood clot in a vein

- High blood pressure

- Severe liver or kidney disease

- Blood pressure > 135 mm systolic or >85 mm diastolic

- Migraine with aura

- Breast cancer or any genital cancer

- Severe chronic liver or kidney disease

- Women with known sensitivity to ethinyl oestradiol, progestogens

- Women taking phenytoin, carbamazepine or phenobarbitol

- Women who are pregnant

- Women who are lactating

- Women who are unwilling to keep a daily menstrual diary or otherwise unwilling to
follow the study criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Sydney centre for Reproductive Health Research, FPNSW - Sydney
Recruitment postcode(s) [1] 0 0
2131 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
Family Planning Association New South Wales
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Merck Sharp & Dohme Corp.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Most Implanon users experience a reduction in the frequency and volume of menstrual bleeding,
but a substantial minority experience unpredictable and frequent and/or prolonged episodes of
bleeding. This is a double blind, placebo controlled, randomised study with an additional
randomised non-blinded arm. Two hundred women between the ages of 18-45 years, who are
Implanon users with prolonged or frequent breakthrough bleeding (WHO definition) will be
recruited and randomised into 4 equal-sized treatment groups of 50 women assigned to Marvelon
7 days or 21 days, NuvaRing 21 days or placebo. Recruited subjects will maintain a daily
menstrual diary chart for a minimum of 90 days prior to randomisation, and will be enrolled
into the treatment phase provided that they have met one of the World Health Organization
criteria for prolonged or frequent bleeding Following the initial 90 day record, eligible
women will begin designated treatment on day 1 of the next episode of bleeding or spotting.
Analysis of the subsequent menstrual pattern will begin from day 1 of that bleeding/spotting
episode and will continue through 90 days.
Trial website
https://clinicaltrials.gov/show/NCT01384331
Trial related presentations / publications
Weisberg E, Hickey M, Palmer D, O'Connor V, Salamonsen LA, Findlay JK, Fraser IS. A randomized controlled trial of treatment options for troublesome uterine bleeding in Implanon users. Hum Reprod. 2009 Aug;24(8):1852-61. doi: 10.1093/humrep/dep081. Epub 2009 Apr 15.
Public notes

Contacts
Principal investigator
Name 0 0
Edith Weisberg, MB BS MM
Address 0 0
Family Planning NSW
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Edith Weisberg, MB BS MM FRANZCOG
Address 0 0
Country 0 0
Phone 0 0
+61 2 8752 4342
Fax 0 0
Email 0 0
edithw@fpnsw.org.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT01384331