New Treatments for Troublesome Bleeding in Implanon Users

NCT01384331 | Unknown Phase 4

• 2 other identifiers: R2011-01ACTRN12611000617965
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Menstrual Problem

Keywords

Implanon users; Frequent bleeding; Prolonged bleeding; Comparison of treatments; Placebo controlled; Randomly allocated tretment

Outcome Measures

Primary Outcomes (1)

• 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

  Within 3 weeks of starting therapy

Secondary Outcomes (1)

• The mean total number of bleeding and spotting days during the 90 day "treatment" reference period

  Six months after entering study

Study Arms (4)

Group 1 Marvelon ,placebo

ACTIVE COMPARATOR

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

Drug: Marvelon

Marvelon

ACTIVE COMPARATOR

* 21 days daily intake of oral capsules containing ethinyl oestradiol 30micrograms plus desogestrel 150 micrograms * for one cycle of 21 days

Drug: Marvelon

NuvaRing

ACTIVE COMPARATOR

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

Drug: Marvelon

Starch capsule

PLACEBO COMPARATOR

21 days daily oral placebo capsules Treatment will be for one 21 day cycle

Drug: Marvelon

Interventions

Marvelon DRUG

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

Also known as: NuvaRing

Group 1 Marvelon ,placebo; Marvelon; NuvaRing; Starch capsule

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Family Planning Association New South Wales: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Sydney centre for Reproductive Health Research, FPNSW

Sydney, New South Wales, 2131, Australia

Location

Related Publications (1)

• 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.

  PMID: 19369294 BACKGROUND

MeSH Terms

Conditions

Menstruation Disturbances

Interventions

Desogestrel; NuvaRing

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Norpregnenes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Edith Weisberg, MB BS MM

  Family Planning NSW

  PRINCIPAL INVESTIGATOR

• Ian S FRASER, BSC MD

  University of Sydney

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Edith Weisberg, MB BS MM FRANZCOG

CONTACT

+61 2 8752 4342; edithw@fpnsw.org.au

Lorraine Edney, RN

CONTACT

+61 2 8752 4381; lorrainee@fpnsw.org.au

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: June 27, 2011
• First Posted: June 29, 2011
• Study Start: July 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: April 1, 2013
• Last Updated: June 29, 2011

Record last verified: 2011-06

Locations

AU (1)