Phase 3 N=394 Treatment

Assessment of the Transfer of Using Levonorgestrel Intrauterine System (LNG IUS) as a Contraceptive to Using it as Part of Hormone Replacement Therapy (HRT).

Menopause

Bottom Line

View on ClinicalTrials.gov: NCT00185458 ↗

Enrolled (actual)

394

Serious AEs

6.4%

Results posted

Nov 2009

Primary outcome: Primary: Number of Bleeding Days — 0; 0; 0; 0 Bleeding days — p=0.128

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: LNG IUS (Drug)
Age: Adult · 46+ yrs
Sex: Female
Sponsor: Bayer
Primary completion: May 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Bleeding Days	0; 0; 0; 0; 0	0.128
PRIMARY Number of Spotting Days	4; 4; 2; 1; 0	0.296
PRIMARY Percentage of Participants With Successful Treatment	31	—
SECONDARY Assessment of QOL as Measured by Women's Health Questionnaire	104.1; 114.4; 112.9	<0.001 sig
SECONDARY Continuation Rates	100.0; 72.3; 23.6	—
SECONDARY Progestogenic Symptom 1: Headache (as Measured by a Visual Analogue Scale (VAS))	23.9; 19.1; 18.2	0.027 sig
SECONDARY Progestogenic Symptom 2: Depressive Mood (as Measured by a VAS)	22.3; 11.8; 14.6	<0.001 sig
SECONDARY Progestogenic Symptom 3: Acne or Greasy Skin (as Measured by a VAS)	8.9; 7.3; 7.6	<0.001 sig
SECONDARY Progestogenic Symptom 4: Nausea (as Measured by a VAS)	7.5; 5.3; 6.7	<0.001 sig
SECONDARY Progestogenic Symptom 5: Edema (as Measured by a VAS)	15.7; 12.3; 11.7	0.054
SECONDARY Progestogenic Symptom 6: Decreased Libido (as Measured by a VAS)	24.9; 15.6; 17.5	<0.001 sig
SECONDARY Climacteric Symptom 1: Hot Flushes (as Measured by a VAS)	39.9; 9.4; 11.3	<0.001 sig
SECONDARY Climacteric Symptom 2: Sweating Episodes (as Measured by a VAS)	43.0; 14.0; 17.0	<0.001 sig
SECONDARY Climacteric Symptom 3: Vaginal Dryness (as Measured by a VAS)	22.8; 13.1; 16.7	<0.001 sig
SECONDARY Climacteric Symptom 4: Sleep Problems (as Measured by a VAS)	39.4; 17.1; 19.9	<0.001 sig
SECONDARY Climacteric Symptom 5: Irritability (as Measured by a VAS)	33.1; 17.2; 19.4	<0.001 sig
SECONDARY Climacteric Symptom 6: Breast Tension (as Measured by a VAS)	15.5; 13.5; 13.0	0.175
SECONDARY Progestogenic Symptom 7: Hair Loss (as Measured by a VAS)	10.0; 9.3; 9.0	0.062
SECONDARY Progestogenic Symptom 8: Greasy Hair (as Measured by a VAS)	14.0; 11.5; 11.1	<0.001 sig

Summary

The study has been designed to look at the transfer from using LNG IUS for contraception only, in reproductive age to using it for endometrial protection in menopausal age. The main area of interest in the study is the pattern of any vaginal bleeding that occurs.

Eligibility Criteria

Inclusion Criteria

Women with intact uterus, regular menstrual cycles and no previous or current climacteric symptoms.

Exclusion Criteria

Pregnancy or lactation.
Previous pelvic infections.
Abnormal bleeding.
Abnormal uterine cavity.
Uterine polyps.
Genital cancer.
Liver diseases.
Alcoholism or drug abuse.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00185458). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.