Trial Outcomes & Findings for Ospemifene vs. Conjugated Estrogens in the Treatment of Postmenopausal Sexual Dysfunction (NCT NCT03018106)

NCT ID: NCT03018106

Last Updated: 2018-01-23

Results Overview

The Female Sexual Function Index (FSFI) is a 19 item questionnaire that asks about sexual function in the prior four weeks. The FSFI was developed for the specific purpose of assessing sexual arousal, orgasm, satisfaction, pain related to sexual functioning in clinical trial participants. Participants answer by selecting between 5-6 question-specific options to rate the degree to which the question fits their experience. Each response option is assigned a point and each question has 0-5 or 1-5 possible points. The points are summed to determine a total score. The total score can range from 2 to 36 and scores equal to or less than 26.55 indicate female sexual dysfunction (FSD).

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 1 participants
• Primary outcome timeframe: Baseline, Week 12
• Results posted on: 2018-01-23

Participant Flow

Participants were enrolled between June 2017 and September 2017

One individual gave informed consent to participate in the study and was randomized to the Estrogen arm.

Participant milestones

Measure	Ospemifene Women randomized to this arm were to receive 60mg oral ospemifene, taken daily, for 12 weeks	Estrogen Women randomized to this arm were to receive 0.5mg vaginal conjugated estrogens, placed vaginally twice per week, for 12 weeks
Overall Study STARTED	0	1
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	Ospemifene Women randomized to this arm were to receive 60mg oral ospemifene, taken daily, for 12 weeks	Estrogen Women randomized to this arm were to receive 0.5mg vaginal conjugated estrogens, placed vaginally twice per week, for 12 weeks
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

Ospemifene vs. Conjugated Estrogens in the Treatment of Postmenopausal Sexual Dysfunction

Baseline characteristics by cohort

Measure	Ospemifene Women randomized to this arm were to receive 60mg oral ospemifene, taken daily, for 12 weeks	Estrogen n=1 Participants Women randomized to this arm were to receive 0.5mg vaginal conjugated estrogens, placed vaginally twice per week, for 12 weeks	Total n=1 Participants Total of all reporting groups
Age, Categorical <=18 years	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	—	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Categorical >=65 years	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	—	51 years STANDARD_DEVIATION 0.0 • n=7 Participants	51 years STANDARD_DEVIATION 0.0 • n=5 Participants
Sex: Female, Male Female	—	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	—	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	—	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	—	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: The single participant was lost to follow up prior to completing the Week 12 assessment.

The Female Sexual Function Index (FSFI) is a 19 item questionnaire that asks about sexual function in the prior four weeks. The FSFI was developed for the specific purpose of assessing sexual arousal, orgasm, satisfaction, pain related to sexual functioning in clinical trial participants. Participants answer by selecting between 5-6 question-specific options to rate the degree to which the question fits their experience. Each response option is assigned a point and each question has 0-5 or 1-5 possible points. The points are summed to determine a total score. The total score can range from 2 to 36 and scores equal to or less than 26.55 indicate female sexual dysfunction (FSD).

Outcome measures

Measure	Estrogen n=1 Participants Women randomized to this arm received 0.5mg vaginal conjugated estrogens, placed vaginally twice per week, for 12 weeks
Female Sexual Function Index Score Baseline	9 units on a scale

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: The single participant was lost to follow up prior to completing the Week 12 assessment.

Participants reported pain with sex at the Baseline Visit and after 12 weeks of treatment. Participants rated the severity of their symptoms from 0 to 3, where 0 = none, 1 = mild, 2 = moderate and 3 = severe.

Outcome measures

Measure	Estrogen n=1 Participants Women randomized to this arm received 0.5mg vaginal conjugated estrogens, placed vaginally twice per week, for 12 weeks
Pain With Sex Baseline	2 units on a scale

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: The single participant was lost to follow up prior to completing the Week 12 assessment.

Participants reported vaginal dryness at the Baseline Visit and after 12 weeks of treatment. Participants rated the severity of their symptoms from 0 to 3, where 0 = none, 1 = mild, 2 = moderate and 3 = severe.

Outcome measures

Measure	Estrogen n=1 Participants Women randomized to this arm received 0.5mg vaginal conjugated estrogens, placed vaginally twice per week, for 12 weeks
Vaginal Dryness Baseline	3 units on a scale

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: The single participant was lost to follow up prior to completing the Week 12 assessment.

Participants reported vaginal itching at the Baseline Visit and after 12 weeks of treatment. Participants rated the severity of their symptoms from 0 to 3, where 0 = none, 1 = mild, 2 = moderate and 3 = severe.

Outcome measures

Measure	Estrogen n=1 Participants Women randomized to this arm received 0.5mg vaginal conjugated estrogens, placed vaginally twice per week, for 12 weeks
Vaginal Itching Baseline	3 units on a scale

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: The single participant was lost to follow up prior to completing the Week 12 assessment.

Participants reported vaginal irritation at the Baseline Visit and after 12 weeks of treatment. Participants rated the severity of their symptoms from 0 to 3, where 0 = none, 1 = mild, 2 = moderate and 3 = severe.

Outcome measures

Measure	Estrogen n=1 Participants Women randomized to this arm received 0.5mg vaginal conjugated estrogens, placed vaginally twice per week, for 12 weeks
Vaginal Irritation Baseline	3 units on a scale

Adverse Events

Estrogen

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Gina Northington, MD

Emory University

Phone: (404) 778-5770

Email: gina.northington@emory.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place